Accessdata.fda.gov

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ALL COUPONS SUBMITTED. Send coupons to: Bayer HealthCare LLC 1355, P.O. Box 880001, El Paso, TX 88588-0001. Cash Value, 1/20th of 1¢. Good only in the U.S.A. MANUFACTURER S COUPON EXPIRES 5/31/18 OFF $1 24 ct or higher on Aleve ® OFF $ …

Actived: Just Now

URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s053lbl.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and …

redeemable coupons (IRCs): • “$3 off” hangtag on stand-alone bottle for 100-ct Aleve ‘caplets’ with Easy Open Arthritis Cap • “$3 off” peel-off principal display panel (PDP) sticker on stand-alone bottle for the 100-ct Aleve ‘caplets’ with Easy Open Arthritis Cap

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CENTER FOR DRUG EVALUATION AND RESEARCH

IRC Sticker $2.00 Off Any “Advil Dual Action” 72-ct or Larger January 31, 2019 IRC Sticker $3.00 Off Any “Advil Dual Action” 72-ct or Larger January 31, 2019 IRC Sticker $2.00 Off Any “Advil Dual Action EZ Open” 144-ct or Larger January 31, 2019 18-Count IRC (Peel-Off PDP) $1.00 Off February 18, 2020

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and …

Hangtag coupon for $1 off 10-count or larger 07/05/18 Hangtag coupon for $2 off 20-count or larger 07/05/18 Hangtag coupon for $3 off 20-count or larger 07/05/18 Hangtag coupon for $3 off 30-count only 07/05/18 Hangtag coupon for $4 off 30-count only 07/05/18 Reference ID: 4370934

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Summary of Safety and Effectiveness Data

Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Refer to . Table V -2 . processes were equivalent for both the stents and coupons utilized during this testing. An . additional series ofbiocompatibility tests were conducted where the amount ofpolymer

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CFR

CFR - Code of Federal Regulations Title 21. The information on this page is current as of April 1 2020. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 1140.1 Scope. (a) This part sets out the restrictions under the Federal Food, Drug, and Cosmetic Act on the sale, distribution, and

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FDA Drug Shortages

U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

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CFR

The information on this page is current as of April 1 2020. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 1140.16 Conditions of manufacture, sale, and distribution. (a) Restriction on product names. A manufacturer shall not use a trade or brand name of a nontobacco product as the

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CFR

The information on this page is current as of April 1 2020. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 1140.10 General responsibilities of manufacturers, distributors, and retailers. Each manufacturer, distributor, importer, and retailer is responsible for ensuring that the

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AUG 2 7 2003

AUG 2 7 2003 S.j& TS03 Chemical Indicator 510(k) Summary - KO21161 Applicant’s Name and Address TSO3 Inc. 2505, Dalton Avenue Sainte-Foy (Quebec) G1P 3S5 Phone : (418) 651-0003 Fax : (418) 653-5726 Email : inforilso3 .corn Contact United States Agent

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Search Orphan Drug Designations and Approvals

Search Orphan Drug Designations and Approvals. This page searches the Orphan Drug Product designation database. Searches may be run by entering the product name, orphan designation, and dates. Results can be displayed as a condensed list, detailed list, or an Excel spreadsheet. Click for detailed instructions.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Silver …

$5 off 70-count (in-pack coupon) $3 off 70-count (in-pack coupon) $5 off 80-count (in-pack coupon) $5 off 90-count (in-pack coupon) $5 off 80-count (IRC) $6 off 90-count (IRC) The FPL should be submitted electronically according to the guidance for industry titled

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and …

Version 1 - In-pack coupon – $3 off Claritin Liqui-Gels 30-ct or higher inserted in the 10-count and 30-count SKUs . March 28, 2018 . Version 2 - In-pack coupon – $4 off Claritin Liqui-Gels 60-ct or higher inserted in the 30-count SKU . March 28, 2018 Version 3 - In-pack coupon – $5 off Claritin Liqui-Gels 60-ct or higher inserted in the

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KEPPRA (levetiracetam) Rx only 250 mg, 500 mg, 750 mg, and

Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Silver …

for Claritin (loratadine) Liqui-Gels capsules, 10 mg and two new in-pack coupons: 60-count carton 70-count (60-count + 10-count bonus) carton Coupon $3 off 60-ct or larger Claritin Liqui-Gels and $5 off 15-ct or larger Claritin-D Coupon $4 off 60-ct or larger Claritin Liqui-Gels and $4 off 15-ct or larger Claritin-D

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and …

Hangtag coupon for $6 off 90-count only 07/06/18 Labeling Item Submission Date PDP coupon for $1 off 5-count or larger 07/06/18 Hangtag coupon for $1 off 10-count or larger 07/06/18 Hangtag coupon for $2 off 30-count or larger 07/06/18 Hangtag coupon for $3 off 30-count or larger 07/06/18 Hangtag coupon for $4 off 60-count only 07/06/18

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BACK PANEL SAVE X NOW!

Coupons cannot be combined. Mail properly handled coupons to: SBF, 815 E. Crosstown Pkwy PMB 50502, Kalamazoo, MI 49001-2505 Omeprazole Delayed Release Tablets 20 mg peel off coupon Reference ID: 3209650. FRONT PANEL BACK PANEL Proposed Draft Labeling NDA 22-032 Omeprazole Delayed Release Tablets, 20 mg

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HIGHLIGHTS OF PRESCRIBING INFORMATION These …

EUCRISA contains 2% crisaborole (w/w) in a petrolatum-based, white to off-white ointment and is for topical use. The active ingredient, crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor. Crisaborole is described chemically as 5-(4-cyanophenoxy)-1,3-dihydro-1-hydroxy-[2,1]-benzoxaborole. The empirical formula is C. 14. H. 10. BNO. 3

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TIKOSYN (dofetilide) Capsules

Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. TIKOSYN capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and …

In-pack coupon – $3 off Claritin Liqui-Gels 30-ct or higher . March 14, 2018 In-pack coupon – $4 off Claritin Liqui-Gels 60-ct or higher . March 14, 2018 In-pack coupon – $5 off Claritin Liqui-Gels 60-ct or higher . March 14, 2018 Reference ID: 4280230

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Rapamune (sirolimus) Oral Solution and Tablets Rx only

Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune® is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a white, triangular-shaped tablet containing 1-mg sirolimus, and as a

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Silver …

carton peel-off coupons (front and back) , the 28-count blister and bottle carton peel-off coupons (front and back) , the 28- and 42-count bottle cartons with “14 FREE” labels, the 42-count blister and bottle carton peel-off coupons (front and back) , the 42-count bottle carton with “28+14

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Silver …

In-pack coupon – Version 1 $2 off any Chewables 30-count or larger January 30, 2018 In-pack coupon – Version 2 $2 off any Chewables 30-count or larger; $3 off any Claritin Tablets or Claritin RediTabs 30-count or larger January 30, 2018 Reference ID: 4294513

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TRULANCE (plecanatide) tablets

3 mg: white to off-white, plain, round tablet debossed with “SP” on one side and “3” for 3 mg on the other side. 4 CONTRAINDICATIONS . TRULANCE is contraindicated in: • Patients less than 6 years of age due to the risk of serious dehydration [see Warnings and Precautions (5.1), Use in …

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IMBRUVICA. IMBRUVICA

Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICA, particularly in patients with cardiac risk factors, acute infections, and a previous

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Silver …

peel-off Instant Rebate Coupons for the 14-, 28-, and 42-count blister and bottle cartons submitted August 13, 2015, and must be in the “Drug Facts” format (21 CFR 201.66), where applicable. Reference ID: 3885681

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PRESCRIBING INFORMATION ARIXTRA

NDA 21-345/S-010 Page 5 surgery, the total clearance of fondaparinux was approximately 25% lower in patients over 75 years old as compared to patients less than 65 years old.

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FPO

Coupons not authorized if purchasing products for resale. Void if transferred, sold, auctioned, reproduced or altered from original. Any art bleeds off 1/16" (.0625") out from die (dotted line for holding only and does not print) no copy 1/16"(.0625") from die dotted line for holding only

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HIGHLIGHTS OF PRESCRIBING INFORMATION ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙

• Patients treated with once weekly OZEMPIC 0.5 mg subcutaneous injection can be transitioned to RYBELSUS 7 mg or 14 mg. Patients can start RYBELSUS up to 7 days after their last injection of

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SOLU-MEDROL (methylprednisolone sodium succinate for

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. Methylprednisolone is a potent anti …

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Silver …

The FPL must be identical to the enclosed labeling (in-pack coupons) described in the table below, and must be in the “Drug Facts” format (21 CFR 201.66), where applicable. Submitted Labeling Date submitted Version 1 – $1 off 4 oz or larger Syrup; $3 off any Chewables 20-ct or larger or RediTabs for Juniors 30-ct March 12, 2018

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sNDA Approval [OTC ONLY] (COR-SNDAACTION-05)

Save $1.00 off any Advil ® PM 20 ct or larger. MANUFACTURER’S COUPON EXPIRES: 12/31/2021. 030573-036472. D000060612. D000060612. Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg Pain Reliever ((NSAID) / Nighttime Sleep-Aid) *Capsule-Shaped Tablets. Coated Caplets * 2020. 20ct. or larger ON ANY. MANUFACTURER'S COUPON EXPIRES 12/31/2021 $ 1

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Reference ID: 4170292

appear as an opaque, white to off-white suspension, evenly mixed with no residual medicine along the side, bottom or top of the inspection window. • Inspect visually for particulate matter and discoloration prior to administration (BYDUREON BCISE contains microspheres which appear as white to off-white particles). Do not use if foreign

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ZOMETA® (zoledronic acid) injection label

Pharmaceuticals Corporation at 1. (2.4 5.3 5.5 5.9 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Silver …

The addition of peel-off Instant Redeemable Coupons (IRCs) to the carton labels and non-child resistant bottle labels. 2. A new packaging configuration that consists of two shrink wrapped cartons to be sold as one new stock keeping unit (SKU). 3. The addition of the statement “XX Free Caplets/Tablets” to the principal display panel

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and …

$3.00 IRC peel-off PDP, 80-ct or larger for 80-ct “Easy Open Cap” immediate container June 13, 2018 The final printed labeling should be submitted electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format — Certain Human

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HIGHLIGHTS OF PRESCRIBING INFORMATION …

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Feraheme safely and effectively. See full prescribing information for

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Zonegran (zonisamide) Package Insert

Zonegran (zonisamide) Package Insert Page 1 of 23 ZONEGRAN® (zonisamide) capsules Rx Only DESCRIPTION ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-

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Food and Drug Administration

art bleeds off 1/16" out from die (dash does not print) no copy 1/16" (.0625") from die (dash line does not print) (.0625") ine LIMIT PER LMT OF 4 LIKE COUPONS it hopping Coupons Mt authorized it prtdæ,s res*e. Void d transferred 2uttior.d, reproduced or torn origin* Any other use comstltutes You map pay saEstas. 00 nr, send to Pfizer Cor.merl

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70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% …

4. If using a new Humulin 70/30 bottle, flip off the plastic protective cap, but . do not remove the stopper. Wipe the top of the bottle with an alcohol swab. 5. Draw an amount of air into the syringe that is equal to the Humulin 70/30 dose. Put the needle through rubber top of the Humulin 70/30 bottle and inject the air into the bottle. 6.

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ADDERALL (CII)

adderall® 5 mg is a white to off-white tablet, which contains no color additives. adderall® 7.5 mg and 10 mg contain fd & c blue #1. adderall® 12.5 mg, 15 mg, 20 mg and 30 …

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ZYVOX

NDA 21-130/S-016/S-017 NDA 21-131/S-013/S-014 NDA 21-132/S-014/S-015 Page 8 Excretion: Nonrenal clearance accounts for approximately 65% of the total clearance of

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CoateCoated Coated

Peel off backing, starting at corner with loose edge. To remove the gum, tear off single unit. Push gum through foil. Free Audio CD upon request. See inside. MANUFACTURER’S COUPON Redeemable at food, drug and mass merchandise stores. CONSUMER: Limit 1 coupon per purchase of indicated product(s). You pay any sales tax.

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Lexapro (escitalopram oxalate) Tablets/Oral Solution NDA

Lexapro (escitalopram oxalate) Tablets/Oral Solution NDA 21-323/NDA 21-365 Proposed Labeling Text . Absorption and Distribution Following a single oral dose (20 mg tablet or solution) of escitalopram, peak blood levels occur at

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HIGHLIGHTS OF PRESCRIBING INFORMATION OPANA ER …

of corticosteroids, and wean patient off of the opioid. (5.7) • Severe Hypotension: Monitor during dose initiation and titration. Avoid use of OPANA ER in patients with circulatory shock. (5.9) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury or Impaired Consciousness: Monitor for sedation

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FIRMAGON -------------WARNINGS AND PRECAUTIONS

The pack contains 1 set of FIRMAGON 80 mg vial, Sterile Water for Injection, USP syringe, vial adapter, and administration needle. For the subcutaneous injection, the drug product must be prepared using the

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Perrigo Nicotine Polacrilex Lozenge 2 mg Drug Facts

Your chances of staying off cigarettes are much better if you start with at least 9 Nicotine Polacrilex Lozenges daily. For best results, use the lozenges on a regular schedule (as outlined in this User's Guide). 3) Start using Nicotine Polacrilex Lozenges on your quit date. 4) This User's Guide outlines a 12-week plan for Nicotine Polacrilex

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Approved Risk Evaluation and Mitigation Strategies (REMS)

Persons with disabilities having problems accessing the PDF file (s) below may call (301) 796-3634 for assistance. The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its

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