Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 074014

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KETOPROFEN (KETOPROFEN)
25MG
Marketing Status: Prescription

Active Ingredient: KETOPROFEN
Proprietary Name: KETOPROFEN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A074014
Product Number: 001
Approval Date: Jan 29, 1993
Applicant Holder Full Name: MISEMER PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

KETOPROFEN (KETOPROFEN)
50MG
Marketing Status: Prescription

Active Ingredient: KETOPROFEN
Proprietary Name: KETOPROFEN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074014
Product Number: 002
Approval Date: Jan 29, 1993
Applicant Holder Full Name: MISEMER PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

KETOPROFEN (KETOPROFEN)
75MG
Marketing Status: Prescription

Active Ingredient: KETOPROFEN
Proprietary Name: KETOPROFEN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A074014
Product Number: 003
Approval Date: Jan 29, 1993
Applicant Holder Full Name: MISEMER PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information