Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202610
Company: THEPHARMANETWORK LLC
Company: THEPHARMANETWORK LLC
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 |
---|---|---|---|---|---|---|---|
10/29/2014 | ORIG-1 | Approval |
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 |