Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075102
Company: SAGENT PHARMS INC

• Other Important Information from FDA

Products on ANDA 075102

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE;INJECTION	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075102

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.

Therapeutic Equivalents for ANDA 075102

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	206408	AVET LIFESCIENCES
PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	205067	DR REDDYS
PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	074848	HIKMA
PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	077908	HOSPIRA
PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	205576	INNOPHARMA
PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	075102	SAGENT PHARMS INC