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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074848
Company: HIKMA

Other Important Information from FDA

Products on ANDA 074848

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 074848

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/074848ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/30/2023	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
07/16/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/16/2020	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/16/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/02/2008	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074848

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

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