Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072573
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE; ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
02/28/1989 | 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 |
---|---|---|---|---|---|
06/03/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/01/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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02/25/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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02/05/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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10/15/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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10/04/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
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01/31/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PRAZOSIN HYDROCHLORIDE
CAPSULE; ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE; ORAL | Prescription | No | AB | 072573 | MYLAN |