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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208301

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NDA 208301 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 208301
Tradename:DICLOFENAC SODIUM
Applicant:Glenmark Pharms Ltd
Ingredient:diclofenac sodium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 208301
Suppliers and Packaging for NDA: 208301
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 208301 ANDA Lake Erie Medical DBA Quality Care Products LLC 55700-511 N 55700-511-00
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 208301 ANDA Glenmark Pharmaceuticals Inc., USA 68462-355 N 68462-355-94

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength3%
Approval Date:Sep 13, 2016TE:ABRLD:No

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