Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085219
Company: AUROLIFE PHARMA LLC
Company: AUROLIFE PHARMA LLC
| 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 |
|---|---|---|---|---|---|---|---|
| 03/12/1979 | 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 |
|---|---|---|---|---|---|
| 08/17/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/29/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 10/19/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 03/28/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 04/06/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/06/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/30/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |