CHILDREN’S MOTRIN از شرکت J AND J CONSUMER INC

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 MOTRIN از شرکت J AND J CONSUMER INC

New Drug Application (NDA): 020516

Company: J AND J CONSUMER INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN’S MOTRIN IBUPROFEN 100MG/5ML SUSPENSION;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
06/16/1995 ORIG-1 Approval

Type 8 – Partial Rx to OTC Switch

STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/19/2021 SUPPL-38 Manufacturing (CMC)-Packaging

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020516Orig1s038lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020516Orig1s038ltr.pdf

11/29/2018 SUPPL-36 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020516Orig1s036lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020516Orig1s036ltr.pdf

03/14/2017 SUPPL-35 Labeling-Package Insert, Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020516Orig1s035ltr.pdf

01/09/2017 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/16/2016 SUPPL-33 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020516Orig1s033lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020516Orig1s033ltr.pdf

06/17/2016 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/07/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/16/2015 SUPPL-30 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020516Orig1s030lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020516Orig1s030ltr.pdf

12/11/2014 SUPPL-29 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020516Orig1s029lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020516Orig1s029ltr.pdf

11/19/2012 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/12/2012 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/06/2011 SUPPL-24 Labeling-Package Insert

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020516s024ltr.pdf

10/19/2010 SUPPL-22 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020516s022ltr.pdf

04/29/2009 SUPPL-21 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020516s021ltr.pdf

06/22/2006 SUPPL-20 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020516s020LTR.pdf

12/07/2005 SUPPL-18 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020516s018ltr.pdf

02/07/2005 SUPPL-16 Manufacturing (CMC)-Formulation

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20516s016ltr.pdf

12/19/2003 SUPPL-12 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20516slr012,21128slr003ltr.pdf

10/28/2003 SUPPL-11 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19012slr034,20516slr011ltr.pdf

05/02/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2000 SUPPL-6 Labeling

Label is not available on this site.

09/13/1999 SUPPL-4 Labeling

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_Approv.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603s002_Ibuprofen.cfm

12/18/1998 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/04/1998 SUPPL-2 Labeling

Label is not available on this site.

03/31/1997 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/19/2021 SUPPL-38

Manufacturing (CMC)-Packaging

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020516Orig1s038lbl.pdf
11/29/2018 SUPPL-36

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020516Orig1s036lbl.pdf
03/14/2017 SUPPL-35

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf
03/14/2017 SUPPL-35

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf
06/16/2016 SUPPL-33

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020516Orig1s033lbl.pdf
04/16/2015 SUPPL-30

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020516Orig1s030lbl.pdf
12/11/2014 SUPPL-29

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020516Orig1s029lbl.pdf
09/13/1999 SUPPL-4

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf

CHILDREN’S MOTRIN

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
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN’S ADVIL IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 020589 GLAXOSMITHKLINE
CHILDREN’S ADVIL-FLAVORED IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 020589 GLAXOSMITHKLINE
CHILDREN’S IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 074937 PERRIGO
CHILDREN’S MOTRIN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter Yes 020516 J AND J CONSUMER INC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 210602 APTAPHARMA INC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 200457 ARISE
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 209179 AUROBINDO PHARMA LTD
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 210149 GUARDIAN DRUG
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 074916 P AND L
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 211666 STRIDES PHARMA
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 209207 TARO
بخوانید  CLINDAMYCIN PHOSPHATE از شرکت BOCA PHARMA LLC
به بالای صفحه بردن