Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084324
Company: LANNETT CO INC
Company: LANNETT CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | 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-70 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2011 | SUPPL-65 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/06/2008 | SUPPL-59 | Labeling |
Label is not available on this site. |
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| 08/06/2007 | SUPPL-56 | Labeling |
Label is not available on this site. |
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| 06/15/1989 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/10/1989 | SUPPL-54 | Bioequivalence |
Label is not available on this site. |
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| 11/22/1983 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/22/1983 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/23/1982 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/23/1982 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |