Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084325
Company: LANNETT CO INC
Company: LANNETT CO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | 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 |
---|---|---|---|---|---|---|---|
06/24/1976 | 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 |
---|---|---|---|---|---|
08/20/2020 | SUPPL-49 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/18/2011 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
03/06/2008 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
08/06/2007 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
03/08/1989 | SUPPL-34 | Bioequivalence |
Label is not available on this site. |
||
11/22/1983 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/22/1983 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/23/1982 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/23/1982 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |