Details for New Drug Application (NDA): 208077
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The generic ingredient in DICLOFENAC SODIUM is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 208077
Tradename: | DICLOFENAC SODIUM |
Applicant: | Amneal Pharms |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Pharmacology for NDA: 208077
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 208077
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 208077 | ANDA | Walgreens | 0363-1210 | 0363-1210-17 | 1 TUBE in 1 CARTON (0363-1210-17) / 50 g in 1 TUBE |
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 208077 | ANDA | Walgreens | 0363-1210 | 0363-1210-35 | 1 TUBE in 1 CARTON (0363-1210-35) / 100 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | GEL;TOPICAL | Strength | 1% | ||||
Approval Date: | Mar 18, 2016 | TE: | RLD: | No |
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