Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020379
Company: PHARMACIA AND UPJOHN
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
12/06/2017 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
12/06/2017 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 PHARMACIA AND UPJOHN
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 PHARMACIA AND UPJOHN
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 PHARMACIA AND UPJOHN
EDEX ALPROSTADIL 0.04MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 020649 AUXILIUM PHARMS LLC

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