ADVIL 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 CONGESTION RELIEF از شرکت GLAXOSMITHKLINE

New Drug Application (NDA): 022565

Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL CONGESTION RELIEF IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 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
05/27/2010 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/2010/022565s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022565s000TOC.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022565s000SumR.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/30/2020 SUPPL-6 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022565Orig1s006lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022565Orig1s006ltr.pdf

07/09/2019 SUPPL-5 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;%20022565Orig1s005ltr.pdf

03/24/2017 SUPPL-3 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022565Orig1s003lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022565Orig1s003ltr.pdf

03/30/2015 SUPPL-2 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022565Orig1s002lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022565Orig1s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/30/2020 SUPPL-6

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022565Orig1s006lbl.pdf
07/09/2019 SUPPL-5

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s007; 022565Orig1s005lbl.pdf
03/24/2017 SUPPL-3

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022565Orig1s003lbl.pdf
03/30/2015 SUPPL-2

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022565Orig1s002lbl.pdf

ADVIL 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; 200MG;10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL CONGESTION RELIEF IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET;ORAL Over-the-counter Yes 022565 GLAXOSMITHKLINE
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET;ORAL Over-the-counter No 203200 PERRIGO R AND D
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