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Application 075239
- Type
- ANDA
- Sponsor
- HOSPIRA
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 | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0409-2339 | Labetalol Hydrochloride | Labetalol Hydrochloride | Hospira, Inc. | ANDA | Current |
| 0409-2339 | Labetalol Hydrochloride | Labetalol Hydrochloride | Hospira, Inc. | ANDA | Current |
| 0409-2339 | Labetalol Hydrochloride | Labetalol Hydrochloride | Hospira, Inc. | ANDA | Current |
| 0409-2339 | Labetalol Hydrochloride | Labetalol Hydrochloride | Hospira, Inc. | ANDA | Current |
| 55154-4747 | Labetalol Hydrochloride | Labetalol Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-4747 | Labetalol Hydrochloride | Labetalol Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-4747 | Labetalol Hydrochloride | Labetalol Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-4747 | Labetalol Hydrochloride | Labetalol Hydrochloride | Cardinal Health | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 62907 | SUPPL | 2020-05-11 |
| 8577 | ORIG | 2004-06-08 |