Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089243
Company: LANNETT
Company: LANNETT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LANIAZID | ISONIAZID | 50MG/5ML | SYRUP;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 |
---|---|---|---|---|---|---|---|
02/03/1986 | 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 |
---|---|---|---|---|---|
01/09/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
09/09/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/09/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/09/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |