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Generated: June 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074986

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NDA 074986 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, Zydus Pharms Usa Inc, Actavis Elizabeth, Allied Pharma Inc, Carlsbad, Casi Pharms Inc, Mylan Pharms Inc, Pliva, Roxane, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Vpna, Actavis Labs Fl Inc, Exela Holdings, and Sandoz, and is included in forty-three NDAs. It is available from seventy-nine 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 074986
Tradename:DICLOFENAC SODIUM
Applicant:Allied Pharma Inc
Ingredient:diclofenac sodium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength50MG
Approval Date:Feb 26, 1999TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength75MG
Approval Date:Feb 26, 1999TE:RLD:No

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Fuji
Citi
Harvard Business School
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