Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087744
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLOROTHIAZIDE-RESERPINE | CHLOROTHIAZIDE; RESERPINE | 250MG;0.125MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/06/1982 | 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 |
|---|---|---|---|---|---|
| 02/05/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/25/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/07/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/12/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/22/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 05/04/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/25/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/18/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |