ADVIL PM از شرکت GLAXOSMITHKLINE

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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): 021394

Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL PM DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG 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
12/21/2005 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
10/02/2018 SUPPL-26 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s026lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021394Orig1s026ltr.pdf

04/18/2018 SUPPL-25 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s025lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021394Orig1s025ltr.pdf

07/21/2017 SUPPL-23 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s023lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021394Orig1s023ltr.pdf

03/30/2017 SUPPL-21 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s021lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021394Orig1s021ltr.pdf

03/15/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/07/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/01/2010 SUPPL-15 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021394s015ltr.pdf

04/25/2011 SUPPL-14 Labeling-Package Insert

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021394s014ltr.pdf

05/19/2009 SUPPL-12 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021394s012ltr.pdf

06/11/2008 SUPPL-10 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021394s010ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/02/2018 SUPPL-26

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s026lbl.pdf
04/18/2018 SUPPL-25

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s025lbl.pdf
07/21/2017 SUPPL-23

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s023lbl.pdf
03/30/2017 SUPPL-21

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s021lbl.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.

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 GLAXOSMITHKLINE
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
حتما بخوانید : ADVIL PM از شرکت GLAXOSMITHKLINE
بخوانید  BRINZOLAMIDE از شرکت WATSON LABS INC
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