ADVIL PM 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 PM از شرکت GLAXOSMITHKLINE

New Drug Application (NDA): 021393

Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL PM DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;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
12/21/2005 ORIG-1 Approval

Type 4 – New Combination

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021393,021394lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021393,021394ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021393,021394_AdvilTOC.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/07/2018 SUPPL-17 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/21393Orig1s017lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/21393Orig1s017ltr.pdf

03/29/2017 SUPPL-14 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021393Orig1s014lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021393Orig1s014ltr.pdf

02/04/2013 SUPPL-12 Manufacturing (CMC)

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021393Orig1s012lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021393Orig1s012ltr.pdf

04/20/2011 SUPPL-7 Labeling-Package Insert

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021393s007ltr.pdf

05/19/2009 SUPPL-6 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021393s006ltr.pdf

06/11/2008 SUPPL-5 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021393s005ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/07/2018 SUPPL-17

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/21393Orig1s017lbl.pdf
03/29/2017 SUPPL-14

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021393Orig1s014lbl.pdf
02/04/2013 SUPPL-12

Manufacturing (CMC)

Label (PDF)

This supplement type does not usually require new labeling.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021393Orig1s012lbl.pdf
12/21/2005 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021393,021394lbl.pdf

ADVIL PM

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

CAPSULE;ORAL; 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL PM DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter Yes 021393 GLAXOSMITHKLINE
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 210676 AUROBINDO PHARMA LTD
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 090397 BIONPHARMA INC
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 200888 STRIDES PHARMA
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