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Generated: November 20, 2018

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Details for New Drug Application (NDA): 200936

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NDA 200936 describes DICLOFENAC SODIUM , which is a drug marketed by Tolmar, Actavis Labs Fl Inc, Amneal Pharms, Exela Holdings, and Sandoz, and is included in five NDAs. It is available from eighty-four 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. Fifteen suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 200936
Tradename:DICLOFENAC SODIUM
Applicant:Tolmar
Ingredient:diclofenac sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200936
Suppliers and Packaging for NDA: 200936
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 200936 ANDA Impax Generics 0115-1483 0115-1483-56 1 TUBE in 1 CARTON (0115-1483-56) > 50 g in 1 TUBE
DICLOFENAC SODIUM diclofenac sodium GEL;TOPICAL 200936 ANDA Impax Generics 0115-1483 0115-1483-61 1 TUBE in 1 CARTON (0115-1483-61) > 100 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength3%
Approval Date:Oct 28, 2013TE:ABRLD:No

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