Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074815
Company: HIKMA

Products on ANDA 074815

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALPROSTADIL	ALPROSTADIL	0.5MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074815

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/1998	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074815ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/11/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
04/03/2001	SUPPL-4	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
07/11/2000	SUPPL-3	Labeling		Label is not available on this site.
07/11/2000	SUPPL-2	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
07/11/2000	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Therapeutic Equivalents for ANDA 074815

ALPROSTADIL

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	MEITHEAL
PROSTIN VR PEDIATRIC	ALPROSTADIL	0.5MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018484	PFIZER