Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074502
Company: PIRAMAL ENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOFLURANE ISOFLURANE 99.9% LIQUID;INHALATION Prescription AN No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/1995 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2009 SUPPL-19 Labeling

Label is not available on this site.

03/14/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/07/2001 SUPPL-12 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/12/2001 SUPPL-11 Labeling

Label is not available on this site.

09/18/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/31/2001 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/18/1996 SUPPL-3 Labeling

Label is not available on this site.

02/28/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/24/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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 ENT

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