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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017989
Company: PFIZER

Products on NDA 017989

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEMABATE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017989

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/1979	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/19/2015	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
06/09/2014	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
12/11/2013	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017989s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017989Orig1s019ltr.pdf
10/15/2002	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
04/03/2000	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
05/11/1998	SUPPL-12	Labeling		Label is not available on this site.
08/29/1995	SUPPL-11	Labeling		Label is not available on this site.
08/29/1995	SUPPL-10	Labeling		Label is not available on this site.
05/08/1992	SUPPL-9	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
09/03/1990	SUPPL-8	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/21/1988	SUPPL-7	Labeling		Label is not available on this site.
09/08/1986	SUPPL-6	Labeling		Label is not available on this site.
05/21/1985	SUPPL-5	Labeling		Label is not available on this site.
08/30/1983	SUPPL-4	Labeling		Label is not available on this site.
12/29/1981	SUPPL-3	Labeling		Label is not available on this site.
03/20/1980	SUPPL-2	Labeling		Label is not available on this site.
03/10/1981	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 017989

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2013	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017989s019lbl.pdf

Therapeutic Equivalents for NDA 017989

HEMABATE

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	217198	ALEMBIC
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	215901	ANI PHARMS
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	217657	GLAND PHARMA LTD
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	218013	MICRO LABS
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	216824	SOLA PHARMS
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	216897	STERISCIENCE
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	213118	SUNNY
HEMABATE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017989	PFIZER

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