Details for New Drug Application (NDA): 203995
✉ Email this page to a colleague
NDA 203995 describes DICLOFENAC SODIUM AND MISOPROSTOL, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Exela Holdings, Micro Labs, Sandoz, Yung Shin Pharm, and Zydus Pharms, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the DICLOFENAC SODIUM AND MISOPROSTOL profile page.
The generic ingredient in DICLOFENAC SODIUM AND MISOPROSTOL 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.
The generic ingredient in DICLOFENAC SODIUM AND MISOPROSTOL 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 203995
| Tradename: | DICLOFENAC SODIUM AND MISOPROSTOL |
| Applicant: | Amneal Pharms |
| Ingredient: | diclofenac sodium; misoprostol |
| Patents: | 0 |
Pharmacology for NDA: 203995
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 203995
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 203995 | ANDA | Amneal Pharmaceuticals LLC | 65162-436 | 65162-436-03 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-436-03) |
| DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 203995 | ANDA | Amneal Pharmaceuticals LLC | 65162-436 | 65162-436-06 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-436-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 50MG;0.2MG | ||||
| Approval Date: | Nov 25, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 75MG;0.2MG | ||||
| Approval Date: | Nov 25, 2016 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
