Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087913
Company: IVAX PHARMS
Company: IVAX PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYCLOTHIAZIDE | METHYCLOTHIAZIDE | 2.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/03/1982 | 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 |
|---|---|---|---|---|---|
| 01/28/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/23/1999 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/20/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/24/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 11/04/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/04/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |