Application 075060
- Type
- ANDA
- Sponsor
- WOCKHARDT BIO AG
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | SYRUP;ORAL | 50MG/5ML | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17856-0093 | Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Atlantic Biologicals Corps | ANDA | Current |
| 17856-0093 | Amantadine Hydrochloride | AMANTADINE HYDROCHLORIDE | Atlantic Biologicals Corps | ANDA | Current |
| 60432-093 | Amantadine Hydrochloride | Amantadine Hydrochloride | Morton Grove Pharmaceuticals, Inc. | ANDA | Current |
| 60687-239 | Amantadine Hydrochloride | Amantadine Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-239 | Amantadine Hydrochloride | Amantadine Hydrochloride | American Health Packaging | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8512 | ORIG | 1998-12-24 |