Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040090
Company: OMNIVIUM PHARMS
Company: OMNIVIUM PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISONIAZID | ISONIAZID | 100MG | TABLET;ORAL | Prescription | AA | No | No |
ISONIAZID | ISONIAZID | 300MG | TABLET;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
06/26/1997 | 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 |
---|---|---|---|---|---|
08/13/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/31/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
ISONIAZID
TABLET;ORAL; 100MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISONIAZID | ISONIAZID | 100MG | TABLET;ORAL | Prescription | No | AA | 080936 | BARR |
ISONIAZID | ISONIAZID | 100MG | TABLET;ORAL | Prescription | No | AA | 040090 | OMNIVIUM PHARMS |
ISONIAZID | ISONIAZID | 100MG | TABLET;ORAL | Prescription | No | AA | 202610 | THEPHARMANETWORK LLC |
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 |