Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017442
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | No |
| MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/23/1976 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/08/2016 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2015 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017442 s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017442Orig1s043ltr.pdf | |
| 07/28/2014 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/2013 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017442s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017442Orig1s041ltr.pdf | |
| 07/10/2009 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017442s035ltr.pdf | |
| 04/06/2009 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017442s033ltr.pdf | |
| 06/12/2001 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17442s29ltr.pdf |
| 05/10/1994 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 08/21/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1988 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/14/1987 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1988 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/1985 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1986 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 02/26/1985 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/13/1984 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/13/1984 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1984 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/01/1984 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/29/1983 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/19/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/19/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1981 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1981 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/1981 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/14/1981 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/10/1979 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/06/1982 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/27/1978 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/14/1977 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/13/1977 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/27/2015 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017442 s043lbl.pdf | |
| 11/04/2013 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017442s041lbl.pdf | |
| 07/10/2009 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s035lbl.pdf | |
| 04/06/2009 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s033lbl.pdf |
MINIPRESS
CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017442 | PFIZER |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217268 | ALEMBIC |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213406 | APPCO |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213052 | AUROBINDO PHARMA LTD |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214608 | GRANULES |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215697 | MANKIND PHARMA |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 072575 | MYLAN |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210971 | NOVITIUM PHARMA |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071745 | TEVA PHARMS |
CAPSULE;ORAL; EQ 1MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017442 | PFIZER |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217268 | ALEMBIC |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213406 | APPCO |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213052 | AUROBINDO PHARMA LTD |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214608 | GRANULES |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071994 | IVAX SUB TEVA PHARMS |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215697 | MANKIND PHARMA |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 072575 | MYLAN |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210971 | NOVITIUM PHARMA |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071745 | TEVA PHARMS |
CAPSULE;ORAL; EQ 2MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017442 | PFIZER |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217268 | ALEMBIC |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213406 | APPCO |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213052 | AUROBINDO PHARMA LTD |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214608 | GRANULES |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215697 | MANKIND PHARMA |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 072575 | MYLAN |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210971 | NOVITIUM PHARMA |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071745 | TEVA PHARMS |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071995 | TEVA PHARMS |