Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074267
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GUANABENZ ACETATE | GUANABENZ ACETATE | EQ 4MG BASE | TABLET;ORAL | Discontinued | None | No | No |
GUANABENZ ACETATE | GUANABENZ ACETATE | EQ 8MG BASE | 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 |
---|---|---|---|---|---|---|---|
06/01/1994 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/23/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/12/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
05/31/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/28/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |