Application 075498
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 1MG BASE | No | No |
| 002 | TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | No | No |
| 003 | TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 5MG BASE | No | No |
| 004 | TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-289 | Terazosin | Terazosin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 33261-211 | Terazosin | Terazosin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-212 | Terazosin | Terazosin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-870 | Terazosin | Terazosin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53808-0306 | Terazosin Hydrochloride | Terazosin Hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0308 | Terazosin Hydrochloride | Terazosin Hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0930 | Terazosin Hydrochloride | Terazosin Hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 68788-9673 | Terazosin | Terazosin | Preferred Pharmaceuticals | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8695 | ORIG | 2001-04-12 |