Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211941
Company: DR REDDYS

Products on ANDA 211941

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211941

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211941Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 211941

CARBOPROST TROMETHAMINE

INJECTABLE;INJECTION; EQ 0.25MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	215337	AMNEAL
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	216882	CAPLIN
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	211941	DR REDDYS
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	216939	EUGIA PHARMA
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	214499	LONG GROVE PHARMS
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	213118	SUNNY
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	216824	WELDING
HEMABATE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017989	PFIZER