Application 207825
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | TABLET, DELAYED RELEASE;ORAL | 10MG;10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-4615 | Doxylamine Succinate and Pyridoxine Hydrochloride | doxylamine succinate and pyridoxine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4615 | Doxylamine Succinate and Pyridoxine Hydrochloride | doxylamine succinate and pyridoxine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |