Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019775
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MINIPRESS XL | PRAZOSIN HYDROCHLORIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
MINIPRESS XL | PRAZOSIN HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
01/29/1992 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/19/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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05/10/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |