Application 207201
- Type
- ANDA
- Sponsor
- HERITAGE PHARMS INC
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GLYCOPYRROLATE | GLYCOPYRROLATE | TABLET;ORAL | 1MG | No | No |
| 002 | GLYCOPYRROLATE | GLYCOPYRROLATE | TABLET;ORAL | 2MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6709 | Glycopyrrolate | Glycopyrrolate | Major Pharmaceuticals | ANDA | Current |
| 0904-6709 | Glycopyrrolate | Glycopyrrolate | Major Pharmaceuticals | ANDA | Current |
| 0904-6709 | Glycopyrrolate | Glycopyrrolate | Major Pharmaceuticals | ANDA | Current |
| 23155-606 | Glycopyrrolate | Glycopyrrolate | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-606 | Glycopyrrolate | Glycopyrrolate | Heritage Pharmaceuticals | ANDA | Current |
| 23155-606 | Glycopyrrolate | Glycopyrrolate | HERITAGE PHARMACEUTICALS INC D/B/A AVET PHARMACEUTICALS INC | ANDA | Current |
| 23155-606 | Glycopyrrolate | Glycopyrrolate | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-606 | Glycopyrrolate | Glycopyrrolate | Heritage Pharmaceuticals Inc | ANDA | Current |
| 23155-607 | Glycopyrrolate | Glycopyrrolate | Heritage Pharmaceuticals | ANDA | Current |
| 23155-607 | Glycopyrrolate | Glycopyrrolate | Heritage Pharmaceuticals Inc | ANDA | Current |
| 23155-607 | Glycopyrrolate | Glycopyrrolate | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-607 | Glycopyrrolate | Glycopyrrolate | HERITAGE PHARMACEUTICALS INC D/B/A AVET PHARMACEUTICALS INC | ANDA | Current |
| 23155-607 | Glycopyrrolate | Glycopyrrolate | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 70518-3031 | Glycopyrrolate | Glycopyrrolate | REMEDYREPACK INC. | ANDA | Current |
| 71335-1458 | Glycopyrrolate | Glycopyrrolate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1458 | Glycopyrrolate | Glycopyrrolate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1458 | Glycopyrrolate | Glycopyrrolate | Bryant Ranch Prepack | ANDA | Current |
| 71335-2075 | Glycopyrrolate | Glycopyrrolate | Bryant Ranch Prepack | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 46675 | ORIG | 2017-01-05 |