Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075367
Company: L PERRIGO CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JUNIOR STRENGTH IBUPROFEN IBUPROFEN 100MG TABLET;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
04/22/1999 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/17/2006 SUPPL-18 Labeling

Label is not available on this site.

08/21/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2001 SUPPL-2 Labeling

Label is not available on this site.

04/27/2000 SUPPL-1 Labeling

Label is not available on this site.

JUNIOR STRENGTH IBUPROFEN

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

TABLET;ORAL; 100MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
JUNIOR STRENGTH ADVIL IBUPROFEN 100MG TABLET;ORAL Over-the-counter No 020267 PFIZER
JUNIOR STRENGTH IBUPROFEN IBUPROFEN 100MG TABLET;ORAL Over-the-counter No 075367 L PERRIGO CO
JUNIOR STRENGTH MOTRIN IBUPROFEN 100MG TABLET;ORAL Over-the-counter No 020602 J AND J CONSUMER INC

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