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Last Updated: August 11, 2020

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Details for New Drug Application (NDA): 090066

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NDA 090066 describes DICLOFENAC SODIUM, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Cipla, Encube, Glenmark Pharms Ltd, Hi Tech, Mylan, Perrigo Uk Finco, Taro, Tolmar, Akorn, Altaire Pharms Inc, Apotex Inc, Bausch And Lomb, Falcon Pharms, Rising, Sandoz Inc, Mylan Labs Ltd, Cadila, Lupin Ltd, Novel Labs Inc, Riconpharma Llc, Teligent Pharma Inc, Twi Pharms, Watson Labs Inc, Actavis Elizabeth, Carlsbad, Casi Pharms Inc, Micro Labs Usa, Mylan Pharms Inc, Pliva, Roxane, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Vpna, Actavis Labs Fl Inc, Exela Holdings, Sandoz, and Yung Shin Pharm, and is included in fifty-one NDAs. It is available from sixty 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. Eleven suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 090066
Tradename:DICLOFENAC SODIUM
Applicant:Unique Pharm Labs
Ingredient:diclofenac sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090066
Suppliers and Packaging for NDA: 090066
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 090066 ANDA Rising Pharmaceuticals, Inc. 16571-202 16571-202-06 60 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-06)
DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 090066 ANDA Rising Pharmaceuticals, Inc. 16571-202 16571-202-10 100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength25MG
Approval Date:Dec 1, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength50MG
Approval Date:Dec 1, 2010TE:ABRLD:No

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