Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088231
Company: DURAMED PHARMS BARR
Company: DURAMED PHARMS BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISONIAZID | ISONIAZID | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/17/1983 | 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 |
|---|---|---|---|---|---|
| 03/26/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 05/03/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 08/17/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 12/29/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/14/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 06/19/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/19/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/19/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/28/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/28/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/05/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |