Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 215397
Company: AMNEAL

Products on ANDA 215397

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE;INJECTION	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215397

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/07/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215397

MEDROXYPROGESTERONE ACETATE

INJECTABLE;INJECTION; 150MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEPO-PROVERA	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AB	020246	PFIZER
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	215397	AMNEAL
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	077235	AMPHASTAR PHARMS INC
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	077334	AMPHASTAR PHARMS INC
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	212824	EUGIA PHARMA
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	212844	EUGIA PHARMA
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	076553	HONG KONG
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	210227	MYLAN LABS LTD