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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074514

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NDA 074514 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-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. Seventeen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

Summary for 074514

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: 074514

Suppliers and Packaging for NDA: 074514

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074514 ANDA Actavis Pharma, Inc. 0228-2550 0228-2550-96 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-96)
DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074514 ANDA Actavis Pharma, Inc. 0228-2550 0228-2550-11 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength50MG
Approval Date:Mar 26, 1996TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength75MG
Approval Date:Mar 26, 1996TE:ABRLD:No


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