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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
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Generated: September 24, 2017

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 Apotex Inc, Glenmark Pharms Ltd, Dexcel Ltd, Falcon Pharms, Actavis Elizabeth, Riconpharma Llc, Amneal Pharms, Taro, Teva, Sandoz Inc, Lupin Ltd, Pliva, Tolmar, Actavis Labs Ut Inc, Akorn, Watson Labs Inc, Mylan, Rising Pharms Inc, Teva Pharms, Unique Pharm Labs, Teligent Pharma Inc, Sandoz, Novel Labs Inc, Mylan Pharms Inc, Altaire Pharms Inc, Carlsbad, Allied Pharma Inc, Roxane, Bausch And Lomb, Vpna, Actavis Mid Atlantic, Twi Pharms Inc, Exela Holdings, and Actavis Labs Fl Inc, and is included in forty-three NDAs. It is available from seventy-three 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. Eighteen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

Summary for NDA: 208301

Tradename:
1
Applicant:
1
Ingredient:
1
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 55700-511-00 1 TUBE in 1 CARTON (55700-511-00) > 100 g in 1 TUBE
DICLOFENAC SODIUM
diclofenac sodium
GEL;TOPICAL 208301 ANDA Glenmark Pharmaceuticals Inc., USA 68462-355 68462-355-94 1 TUBE in 1 CARTON (68462-355-94) > 100 g in 1 TUBE

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
McKesson
Chubb
Citi
Farmers Insurance
AstraZeneca
Julphar
Covington
Healthtrust
Teva

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