Details for New Drug Application (NDA): 200936
✉ 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. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
Summary for 200936
Tradename: | DICLOFENAC SODIUM |
Applicant: | Amneal |
Ingredient: | diclofenac sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 200936
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Decreased Prostaglandin Production |
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 | Asclemed USA, Inc. | 76420-025 | 76420-025-01 | 100 g in 1 TUBE (76420-025-01) |
DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 200936 | ANDA | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0234 | 80425-0234-1 | 1 TUBE in 1 CARTON (80425-0234-1) / 100 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 3% | ||||
Approval Date: | Oct 28, 2013 | TE: | AB | RLD: | No |
Complete Access Available with Subscription