Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214475

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FENOPROFEN CALCIUM (FENOPROFEN CALCIUM)
EQ 200MG BASE
Marketing Status: Prescription

Active Ingredient: FENOPROFEN CALCIUM
Proprietary Name: FENOPROFEN CALCIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214475
Product Number: 002
Approval Date: Jul 26, 2024
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FENOPROFEN CALCIUM (FENOPROFEN CALCIUM)
EQ 300MG BASE
Marketing Status: Prescription

Active Ingredient: FENOPROFEN CALCIUM
Proprietary Name: FENOPROFEN CALCIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214475
Product Number: 003
Approval Date: Jul 26, 2024
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FENOPROFEN CALCIUM (FENOPROFEN CALCIUM)
EQ 400MG BASE
Marketing Status: Prescription

Active Ingredient: FENOPROFEN CALCIUM
Proprietary Name: FENOPROFEN CALCIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A214475
Product Number: 001
Approval Date: Jul 18, 2022
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information