Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079113
Company: PERRIGO R AND D
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN AND DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG TABLET;ORAL Over-the-counter None 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
12/22/2008 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/079113Orig1Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2016 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

12/31/2014 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

IBUPROFEN AND DIPHENHYDRAMINE CITRATE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 38MG;200MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL PM DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG TABLET;ORAL Over-the-counter Yes 021394 PFIZER
IBUPROFEN AND DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG TABLET;ORAL Over-the-counter No 090619 DR REDDYS LABS LTD
IBUPROFEN AND DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG TABLET;ORAL Over-the-counter No 079113 PERRIGO R AND D

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