Application 206391
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS SA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NITROGLYCERIN | NITROGLYCERIN | TABLET;SUBLINGUAL | 0.3MG | No | No |
| 002 | NITROGLYCERIN | NITROGLYCERIN | TABLET;SUBLINGUAL | 0.4MG | No | No |
| 003 | NITROGLYCERIN | NITROGLYCERIN | TABLET;SUBLINGUAL | 0.6MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68071-4343 | Nitroglycerin | Nitroglycerin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68462-638 | Nitroglycerin | Nitroglycerin | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-638 | Nitroglycerin | Nitroglycerin | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-639 | Nitroglycerin | Nitroglycerin | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-639 | Nitroglycerin | Nitroglycerin | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-640 | Nitroglycerin | Nitroglycerin | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-640 | Nitroglycerin | Nitroglycerin | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 70518-2910 | Nitroglycerin | Nitroglycerin | REMEDYREPACK INC. | ANDA | Current |
| 71872-7033 | Nitroglycerin | Nitroglycerin | Medical Purchasing Solutions, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 49843 | ORIG | 2017-09-22 |