Application 202840
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-297 | Memantine Hydrochloride | Memantine Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-297 | Memantine Hydrochloride | Memantine Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-297 | Memantine Hydrochloride | Memantine Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-297 | Memantine Hydrochloride | Memantine Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-298 | Memantine Hydrochloride | Memantine Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-298 | Memantine Hydrochloride | Memantine Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-298 | Memantine Hydrochloride | Memantine Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-298 | Memantine Hydrochloride | Memantine Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 50090-5832 | Memantine Hydrochloride | Memantine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5832 | Memantine Hydrochloride | Memantine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 68788-7165 | Memantine Hydrochloride | Memantine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7165 | Memantine Hydrochloride | Memantine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7165 | Memantine Hydrochloride | Memantine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7165 | Memantine Hydrochloride | Memantine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32325 | ORIG | 2014-08-29 |