Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022113
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL ALLERGY AND CONGESTION RELIEF CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 4MG;200MG;10MG TABLET;ORAL Over-the-counter None Yes Yes
ADVIL MULTI-SYMPTOM COLD & FLU CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 4MG;200MG;10MG TABLET;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/21/2011 ORIG-1 Approval Type 4 - New Combination STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022113s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022113_advil_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022113Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2017 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

04/28/2017 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022113Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022113Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2017 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022113Orig1s001lbl.pdf

ADVIL ALLERGY AND CONGESTION RELIEF

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

TABLET;ORAL; 4MG;200MG;10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL ALLERGY AND CONGESTION RELIEF CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 4MG;200MG;10MG TABLET;ORAL Over-the-counter Yes 022113 PFIZER
ADVIL MULTI-SYMPTOM COLD & FLU CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 4MG;200MG;10MG TABLET;ORAL Over-the-counter Yes 022113 PFIZER

ADVIL MULTI-SYMPTOM COLD & FLU

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

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