Application 040673
- Type
- ANDA
- Sponsor
- QUAGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | No | No |
| 002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 23155-067 | Promethazine hydrochloride | Promethazine hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-068 | Promethazine hydrochloride | Promethazine hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-069 | Promethazine hydrochloride | Promethazine hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44194 | ORIG | 2008-03-10 |