Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088882
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETAZOLAMIDE | ACETAZOLAMIDE | 250MG | 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 |
---|---|---|---|---|---|---|---|
10/22/1985 | 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 |
---|---|---|---|---|---|
04/25/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/03/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
01/28/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/31/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/15/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/15/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/15/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |