Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020379
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAVERJECT | ALPROSTADIL | 0.01MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
| CAVERJECT | ALPROSTADIL | 0.02MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| CAVERJECT | ALPROSTADIL | 0.005MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CAVERJECT | ALPROSTADIL | 0.04MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/06/1995 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 12/23/2022 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020379s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020379Orig1s038ltr.pdf | |
| 12/06/2017 | SUPPL-34 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020379s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020379s034ltr.pdf | |
| 12/06/2017 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020379s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020379s032ltr.pdf | |
| 12/06/2017 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020379s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020379s031ltr.pdf | |
| 05/05/2016 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020379s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020379Orig1s030ltr.pdf | |
| 06/12/2014 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020379s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020379Orig1s028ltr.pdf | |
| 06/09/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/2016 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/2003 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20379slr017,20755slr005,21212slr002ltr.pdf |
| 10/15/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/2001 | 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. |
||
| 11/29/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/02/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/15/2002 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20379s11ltr.pdf |
| 01/20/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/26/1998 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20379-s009_caverject.pdf |
| 05/20/1998 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1997 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/08/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/21/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/28/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/27/1996 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/13/1996 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/19/1996 | 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 |
|---|---|---|---|---|---|
| 12/23/2022 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020379s038lbl.pdf | |
| 12/06/2017 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020379s034lbl.pdf | |
| 12/06/2017 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020379s032lbl.pdf | |
| 12/06/2017 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020379s031lbl.pdf | |
| 05/05/2016 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020379s030lbl.pdf | |
| 06/12/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020379s028lbl.pdf |
CAVERJECT
INJECTABLE;INJECTION; 0.01MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAVERJECT | ALPROSTADIL | 0.01MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020379 | PFIZER |
| EDEX | ALPROSTADIL | 0.01MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020649 | AUXILIUM PHARMS LLC |
INJECTABLE;INJECTION; 0.02MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAVERJECT | ALPROSTADIL | 0.02MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020379 | PFIZER |
| EDEX | ALPROSTADIL | 0.02MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020649 | AUXILIUM PHARMS LLC |
INJECTABLE;INJECTION; 0.04MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAVERJECT | ALPROSTADIL | 0.04MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020379 | PFIZER |
| EDEX | ALPROSTADIL | 0.04MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020649 | AUXILIUM PHARMS LLC |