Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROSTIN VR PEDIATRIC | ALPROSTADIL | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
10/16/1981 | 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 |
---|---|---|---|---|---|
07/18/2019 | SUPPL-28 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018484Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018484Orig1s028ltr.pdf | |
06/09/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/17/2002 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/01/2002 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/13/2001 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/03/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/15/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
06/26/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
05/04/1994 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/26/1993 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/10/1995 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/11/1992 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/28/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
07/10/1987 | SUPPL-5 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
04/14/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/31/1988 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/28/1987 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/29/1982 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/18/2019 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018484Orig1s028lbl.pdf |
PROSTIN VR PEDIATRIC
INJECTABLE;INJECTION; 0.5MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ALPROSTADIL | ALPROSTADIL | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074815 | HIKMA |
ALPROSTADIL | ALPROSTADIL | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075196 | TEVA PHARMS USA |
PROSTIN VR PEDIATRIC | ALPROSTADIL | 0.5MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018484 | PFIZER |