Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075196
Company: MEITHEAL

Products on ANDA 075196

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 075196

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/1999	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/19/2020	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
06/19/2020	SUPPL-20	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 075196

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