Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210755
Company: GUARDIAN DRUG
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
09/26/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

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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