Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076925
Company: PERRIGO R AND D
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Prescription AB 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
09/23/2004 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
04/18/2017 SUPPL-36 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/09/2016 SUPPL-33 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

08/13/2013 SUPPL-29 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/04/2008 SUPPL-20 Labeling

Label is not available on this site.

07/03/2006 SUPPL-11 Labeling

Label is not available on this site.

03/22/2006 SUPPL-10 Labeling

Label is not available on this site.

IBUPROFEN

SUSPENSION;ORAL; 100MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Prescription No AB 074978 ACTAVIS MID ATLANTIC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Prescription No AB 205647 HI TECH
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Prescription No AB 076925 PERRIGO R AND D
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Prescription No AB 209204 TARO

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