Drugs@FDA: FDA-Approved Drugs
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISONIAZID | ISONIAZID | 300MG | TABLET;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/24/1972 | 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 |
|---|---|---|---|---|---|
| 12/21/1999 | SUPPL-56 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/09/2000 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2000 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2000 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2000 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 03/09/2000 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1997 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 09/18/1997 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1990 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 04/06/1987 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1986 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1985 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1986 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1986 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1985 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
ISONIAZID
TABLET;ORAL; 300MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ISONIAZID | ISONIAZID | 300MG | TABLET;ORAL | Prescription | No | AA | 080937 | BARR |
| ISONIAZID | ISONIAZID | 300MG | TABLET;ORAL | Prescription | No | AA | 040090 | OMNIVIUM PHARMS |
| ISONIAZID | ISONIAZID | 300MG | TABLET;ORAL | Prescription | No | AA | 202610 | THEPHARMANETWORK LLC |