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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017989
Company: PFIZER

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

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.

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

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 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 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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