CHILDREN’S IBUPROFEN از شرکت PERRIGO

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 IBUPROFEN از شرکت PERRIGO

Abbreviated New Drug Application (ANDA): 074937

Company: PERRIGO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN’S IBUPROFEN IBUPROFEN 100MG/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
12/22/1998 ORIG-1 Approval

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-937_Ibuprofen_prntlbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74937ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-937_Ibuprofen.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/18/2011 SUPPL-57 Labeling-Package Insert

Label is not available on this site.

03/17/2006 SUPPL-40 Labeling

Label is not available on this site.

08/02/2002 SUPPL-24 Labeling

Label is not available on this site.

11/26/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/2001 SUPPL-21 Labeling

Label is not available on this site.

08/21/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/2001 SUPPL-19 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/30/2001 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/30/2001 SUPPL-17 Labeling

Label is not available on this site.

07/30/2001 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/2001 SUPPL-14 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/30/2001 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/30/2001 SUPPL-12 Labeling

Label is not available on this site.

07/30/2001 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/2001 SUPPL-9 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/30/2001 SUPPL-7 Labeling

Label is not available on this site.

07/30/2001 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/2001 SUPPL-4 Labeling

Label is not available on this site.

01/28/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1999 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
12/22/1998 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-937_Ibuprofen_prntlbl.pdf

CHILDREN’S IBUPROFEN

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
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