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Details for New Drug Application (NDA): 204132

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NDA 204132 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-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: 204132

Pharmacology for NDA: 204132

Suppliers and Packaging for NDA: 204132

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
diclofenac sodium
SOLUTION;TOPICAL 204132 ANDA Sircle Laboratories, LLC 51021-250 51021-250-05 150 mL in 1 BOTTLE (51021-250-05)
diclofenac sodium
SOLUTION;TOPICAL 204132 ANDA Sircle Laboratories, LLC 51021-374 51021-374-01 1 KIT in 1 CARTON (51021-374-01) * 150 mL in 1 BOTTLE (51021-250-05) * 234 g in 1 BOTTLE, PLASTIC (64058-247-68)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength1.5%
Approval Date:Aug 20, 2015TE:ATRLD:No

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