Details for New Drug Application (NDA): 206116
✉ Email this page to a colleague
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 206116
Tradename: | DICLOFENAC SODIUM |
Applicant: | Amneal Pharms |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206116
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 206116
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 206116 | ANDA | A-S Medication Solutions | 50090-3316 | 50090-3316-0 | 1 BOTTLE in 1 CARTON (50090-3316-0) / 150 mL in 1 BOTTLE |
DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 206116 | ANDA | UNIT DOSE SERVICES | 50436-3340 | 50436-3340-1 | 1 BOTTLE in 1 CARTON (50436-3340-1) / 150 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 1.5% | ||||
Approval Date: | Sep 2, 2016 | TE: | AT | RLD: | No |
Complete Access Available with Subscription