Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017989
Company: PHARMACIA AND UPJOHN
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 211941 DR REDDYS LABS LTD
HEMABATE CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 017989 PHARMACIA AND UPJOHN

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English