Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084233
Company: INVATECH
Company: INVATECH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Discontinued | None | No | No |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/08/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/17/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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