Application 040337
- Type
- ANDA
- Sponsor
- HIKMA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | TABLET;ORAL | 2MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-1763 | Trihexyphenidyl Hydrochloride | Trihexyphenidyl Hydrochloride | West-ward Pharmaceutical Corp | ANDA | Current |
| 0143-1764 | Trihexyphenidyl Hydrochloride | Trihexyphenidyl Hydrochloride | West-ward Pharmaceutical Corp | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 7629 | ORIG | 2000-02-16 |