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Application 212990
- Type
- ANDA
- Sponsor
- EPIC PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 002 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No |
| 003 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42806-327 | Labetalol Hydrochloride | Labetalol Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-328 | Labetalol Hydrochloride | Labetalol Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-329 | Labetalol Hydrochloride | Labetalol Hydrochloride | Epic Pharma, LLC | ANDA | Current |