Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074989
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET;ORAL | Discontinued | None | No | No |
LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/30/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74989ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74989_Labetalol%20Hydrochloride.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/24/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/07/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |