Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085672
Company: ABC HOLDING
Company: ABC HOLDING
| 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 |
|---|---|---|---|---|---|---|---|
| 06/02/1977 | 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 |
|---|---|---|---|---|---|
| 03/13/1996 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 08/02/1995 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 03/13/1995 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 07/15/1993 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 11/13/1991 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 07/25/1991 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 08/03/1990 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 08/03/1990 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 10/31/1988 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 03/24/1988 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/06/1983 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/24/1983 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |