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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020649
Company: AUXILIUM PHARMS LLC

Products on NDA 020649

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020649

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.

Labels for NDA 020649

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

Therapeutic Equivalents for NDA 020649

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	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

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