Product NDC: | 55648-217 |
Proprietary Name: | Diclofenac Sodium and Misoprostol |
Non Proprietary Name: | Diclofenac Sodium and Misoprostol |
Active Ingredient(s): | 75; .2 mg/1; mg/1 & nbsp; Diclofenac Sodium and Misoprostol |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, DELAYED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 55648-217 |
Labeler Name: | Wockhardt Limited |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA201948 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120815 |
Package NDC: | 55648-217-02 |
Package Description: | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (55648-217-02) |
NDC Code | 55648-217-02 |
Proprietary Name | Diclofenac Sodium and Misoprostol |
Package Description | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (55648-217-02) |
Product NDC | 55648-217 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Diclofenac Sodium and Misoprostol |
Dosage Form Name | TABLET, DELAYED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20120815 |
Marketing Category Name | ANDA |
Labeler Name | Wockhardt Limited |
Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
Strength Number | 75; .2 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] |