Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205067
Company: DR REDDYS

Products on ANDA 205067

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 205067

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/2018	ORIG-1	Approval		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
08/30/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205067

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	217525	AMNEAL
PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	217013	ASPIRO
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