Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020649
Company: AUXILIUM PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EDEX ALPROSTADIL 0.005MG/VIAL INJECTABLE;INJECTION Discontinued None No No
EDEX ALPROSTADIL 0.01MG/VIAL INJECTABLE;INJECTION Prescription AP Yes No
EDEX ALPROSTADIL 0.02MG/VIAL INJECTABLE;INJECTION Prescription AP Yes No
EDEX ALPROSTADIL 0.04MG/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
EDEX ALPROSTADIL 0.01MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
EDEX ALPROSTADIL 0.02MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
EDEX ALPROSTADIL 0.04MG/VIAL INJECTABLE;INJECTION Prescription None 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
06/12/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020649_edex_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2016 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/09/2015 SUPPL-23 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020649s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020649Orig1s023ltr.pdf
03/12/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/11/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/09/2006 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020649s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020649s015LTR.pdf
12/14/2001 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/01/2000 SUPPL-12 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/31/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1999 SUPPL-9 Labeling

Label is not available on this site.

10/15/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/20/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/19/1999 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/20/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1998 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/01/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/30/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1997 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
03/09/2015 SUPPL-23 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020649s023lbl.pdf
06/09/2006 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020649s015lbl.pdf

EDEX

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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