Application 075303
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9320 | Labetalol Hydrochloride | Labetalol Hydrochloride | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9622 | Labetalol Hydrochloride | Labetalol Hydrochloride | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9623 | Labetalol Hydrochloride | Labetalol Hydrochloride | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 51662-1602 | LABETALOL HCl | LABETALOL HCl | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1602 | LABETALOL HCl | LABETALOL HCl | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 72572-350 | Labetalol Hydrochloride | Labetalol Hydrochloride | Civica, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8609 | ORIG | 1999-05-28 |