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Details for New Drug Application (NDA): 074432

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NDA 074432 describes DICLOFENAC SODIUM, which is a drug marketed by Apotex Inc, Glenmark Pharms Ltd, Dexcel Ltd, Falcon Pharms, Actavis Elizabeth, Amneal Pharms, Taro, Teva, Alcon Pharms Ltd, Lupin Ltd, Pliva, Tolmar, 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, Nostrum Labs, Roxane, Bausch And Lomb, Vpna, Actavis Mid Atlantic, Paddock Llc, Exela Pharma Scs Llc, and Actavis Labs Fl Inc, and is included in forty NDAs. It is available from sixty-seven suppliers. Additional details are available on the DICLOFENAC SODIUM profile page.

The generic ingredient in DICLOFENAC SODIUM is diclofenac sodium; misoprostol. There are forty-six 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: 074432

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength50MG
Approval Date:Jul 29, 1999TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength75MG
Approval Date:Jul 29, 1999TE:RLD:No

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