Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075392
Company: TEVA PARENTERAL

• Other Important Information from FDA

Products on ANDA 075392

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPOFOL	PROPOFOL	10MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075392

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75392_Propofol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75392ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075392_propofol_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/17/2002	SUPPL-4	Labeling		Label is not available on this site.
03/06/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
11/16/2000	SUPPL-2	Labeling		Label is not available on this site.
03/20/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075392

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/19/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75392_Propofol_Prntlbl.pdf