ADVIL ALLERGY AND CONGESTION RELIEF از شرکت GLAXOSMITHKLINE

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ADVIL ALLERGY AND CONGESTION RELIEF از شرکت GLAXOSMITHKLINE

New Drug Application (NDA): 022113

Company: GLAXOSMITHKLINE

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
09/06/2019 SUPPL-8 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022113Orig1s008ltr.pdf

07/09/2019 SUPPL-7 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s007; 022565Orig1s005lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022113Orig1s007; 022565Orig1s005ltr.pdf

01/25/2019 SUPPL-5 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s005lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022113Orig1s005ltr.pdf

02/26/2018 SUPPL-4 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s004lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022113Orig1s004ltr.pdf

02/26/2018 SUPPL-3 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s003lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022113Orig1s003ltr.pdf

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
09/06/2019 SUPPL-8

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s008lbl.pdf
07/09/2019 SUPPL-7

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s007; 022565Orig1s005lbl.pdf
01/25/2019 SUPPL-5

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s005lbl.pdf
02/26/2018 SUPPL-4

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s004lbl.pdf
02/26/2018 SUPPL-3

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022113Orig1s003lbl.pdf
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 GLAXOSMITHKLINE
ADVIL MULTI-SYMPTOM COLD & FLU CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 4MG;200MG;10MG TABLET;ORAL Over-the-counter Yes 022113 GLAXOSMITHKLINE

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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