Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075217
Company: L PERRIGO CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 40MG/ML SUSPENSION/DROPS;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
12/16/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-217_Ibuprofen_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75217ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-217_Ibuprofen.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2011 SUPPL-38 Labeling-Container/Carton Labels

Label is not available on this site.

03/22/2006 SUPPL-26 Labeling

Label is not available on this site.

05/22/2003 SUPPL-9 Labeling

Label is not available on this site.

08/21/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/2001 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/18/2000 SUPPL-4 Labeling

Label is not available on this site.

05/24/2000 SUPPL-3 Labeling

Label is not available on this site.

05/24/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-217_Ibuprofen_prntlbl.pdf

IBUPROFEN

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

SUSPENSION/DROPS;ORAL; 40MG/ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S MOTRIN IBUPROFEN 40MG/ML SUSPENSION/DROPS;ORAL Over-the-counter Yes 020603 J AND J CONSUMER INC
IBUPROFEN IBUPROFEN 40MG/ML SUSPENSION/DROPS;ORAL Over-the-counter No 210755 GUARDIAN DRUG
IBUPROFEN IBUPROFEN 40MG/ML SUSPENSION/DROPS;ORAL Over-the-counter No 075217 L PERRIGO CO
IBUPROFEN IBUPROFEN 40MG/ML SUSPENSION/DROPS;ORAL Over-the-counter No 079058 TRIS PHARMA INC

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