CHILDREN’S ADVIL COLD 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

CHILDREN’S ADVIL COLD از شرکت GLAXOSMITHKLINE

New Drug Application (NDA): 021373

Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN’S ADVIL COLD IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;ORAL Over-the-counter

None

No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/18/2002 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21373ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-373_Ibuprofen%20Childrens%20Advil.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2017 SUPPL-13 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021373Orig1s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021373Orig1s013ltr.pdf

12/07/2012 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/24/2010 SUPPL-11 Labeling-Package Insert

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021373s011ltr.pdf

05/19/2009 SUPPL-9 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021373s009ltr.pdf

12/03/2008 SUPPL-8 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021373s008ltr.pdf

04/04/2006 SUPPL-5 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021373s005ltr.pdf

01/12/2005 SUPPL-3 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21373s003ltr.pdf

03/25/2003 SUPPL-1 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21373slr001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/24/2017 SUPPL-13

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021373Orig1s013lbl.pdf
04/18/2002 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf

CHILDREN’S ADVIL COLD

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

SUSPENSION;ORAL; 100MG/5ML;15MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN’S ADVIL COLD IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;ORAL Over-the-counter No 021373 GLAXOSMITHKLINE
CHILDREN’S MOTRIN COLD IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;ORAL Over-the-counter Yes 021128 J AND J CONSUMER INC
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;ORAL Over-the-counter No 076478 PERRIGO
بخوانید  ADVIL LIQUI-GELS از شرکت GLAXOSMITHKLINE
به بالای صفحه بردن