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): 020601

Company: J AND J CONSUMER INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN’S MOTRIN IBUPROFEN 50MG TABLET, CHEWABLE;ORAL Discontinued

None

Yes No
JUNIOR STRENGTH MOTRIN IBUPROFEN 100MG TABLET, CHEWABLE;ORAL Discontinued

None

Yes 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
11/15/1996 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
10/02/2018 SUPPL-21 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020601Orig1s021lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020601Orig1s021ltr.pdf

05/15/2017 SUPPL-20 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020601Orig1s020lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020601Orig1s020ltr.pdf

10/18/2010 SUPPL-18 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020601s018ltr.pdf

04/28/2009 SUPPL-17 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020601s017ltr.pdf

05/10/2006 SUPPL-14 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020601s014ltr.pdf

02/27/2006 SUPPL-13 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020601s013ltr.pdf

08/05/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1999 SUPPL-5 Labeling

Label is not available on this site.

12/29/1999 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

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

Label is not available on this site.

09/13/1999 SUPPL-2 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

06/12/1998 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
10/02/2018 SUPPL-21

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020601Orig1s021lbl.pdf
05/15/2017 SUPPL-20

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020601Orig1s020lbl.pdf
09/13/1999 SUPPL-2

Labeling

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