Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075225
Company: HALOCARBON PRODS

Products on ANDA 075225

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOFLURANE	ISOFLURANE	99.9%	LIQUID;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075225

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75225ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2020	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 075225

ISOFLURANE

LIQUID;INHALATION; 99.9%
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FORANE	ISOFLURANE	99.9%	LIQUID;INHALATION	Prescription	Yes	AN	017624	BAXTER HLTHCARE
ISOFLURANE	ISOFLURANE	99.9%	LIQUID;INHALATION	Prescription	No	AN	075225	HALOCARBON PRODS
ISOFLURANE	ISOFLURANE	99.9%	LIQUID;INHALATION	Prescription	No	AN	074416	PIRAMAL CRITICAL
ISOFLURANE	ISOFLURANE	99.9%	LIQUID;INHALATION	Prescription	No	AN	074502	PIRAMAL PHARMA