Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075102
Company: SAGENT PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPOFOL PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/04/1999 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75102_Propofol.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2017 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

07/05/2016 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

11/19/2015 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

12/18/2012 SUPPL-28 Labeling-Container/Carton Labels

Label is not available on this site.

02/25/2009 SUPPL-14 Labeling

Label is not available on this site.

03/10/2005 SUPPL-13 Labeling

Label is not available on this site.

02/08/2005 SUPPL-11 Labeling

Label is not available on this site.

09/11/2002 SUPPL-9 Labeling

Label is not available on this site.

09/11/2002 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/11/2002 SUPPL-7 Manufacturing (CMC)-New Strength

Label is not available on this site.

03/06/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/2000 SUPPL-5 Labeling

Label is not available on this site.

02/10/2000 SUPPL-4 Labeling

Label is not available on this site.

05/14/1999 SUPPL-3 Labeling

Label is not available on this site.

03/23/1999 SUPPL-2 Labeling

Label is not available on this site.

07/28/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PROPOFOL

INJECTABLE;INJECTION; 10MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIPRIVAN PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription Yes AB 019627 FRESENIUS KABI USA
PROPOFOL PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription No AB 205067 DR REDDYS
PROPOFOL PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription No AB 077908 HOSPIRA
PROPOFOL PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription No AB 075102 SAGENT PHARMS INC
PROPOFOL PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription No AB 205307 WATSON LABS INC

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