Application 201831
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | TABLET;ORAL | 0.1MG | No | No |
| 002 | DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | TABLET;ORAL | 0.2MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-883 | Desmopressin Acetate | Desmopressin Acetate | Northstar Rx LLC | ANDA | Current |
| 16714-884 | Desmopressin Acetate | Desmopressin Acetate | Northstar Rx LLC | ANDA | Current |
| 68001-325 | Desmopressin Acetate | Desmopressin Acetate | BluePoint Laboratories | ANDA | Current |
| 68001-325 | Desmopressin Acetate | Desmopressin Acetate | BluePoint Laboratories | ANDA | Current |
| 68001-326 | Desmopressin Acetate | Desmopressin Acetate | BluePoint Laboratories | ANDA | Current |
| 68001-326 | Desmopressin Acetate | Desmopressin Acetate | BluePoint Laboratories | ANDA | Current |
| 68462-275 | Desmopressin Acetate | Desmopressin Acetate | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 68462-275 | Desmopressin Acetate | Desmopressin Acetate | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 68462-276 | Desmopressin Acetate | Desmopressin Acetate | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 68462-276 | Desmopressin Acetate | Desmopressin Acetate | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 70518-3125 | Desmopressin Acetate | Desmopressin Acetate | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32141 | ORIG | 2015-05-29 |