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Fuji
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US Department of Justice
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208077

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NDA 208077 describes DICLOFENAC SODIUM, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Glenmark Pharms Ltd, Taro, Tolmar, Akorn, Altaire Pharms Inc, Apotex Inc, Bausch And Lomb, Falcon Pharms, Rising Pharms Inc, Sandoz Inc, Anda Repository, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Watson Labs Inc, Actavis Elizabeth, Allied Pharma Inc, Carlsbad, Mylan Pharms Inc, Pliva, Roxane, Sandoz, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Vpna, Actavis Labs Fl Inc, and Exela Holdings, and is included in forty-two NDAs. It is available from seventy-eight suppliers. Additional details are available on the DICLOFENAC SODIUM profile page.

The generic ingredient in DICLOFENAC SODIUM is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 208077
Tradename:DICLOFENAC SODIUM
Applicant:Amneal Pharms
Ingredient:diclofenac sodium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 208077
Suppliers and Packaging for NDA: 208077
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 208077 ANDA AvKARE, Inc. 42291-256 N 42291-256-11
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 208077 ANDA Proficient Rx LP 63187-762 N 63187-762-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1%
Approval Date:Mar 18, 2016TE:ABRLD:No

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