Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017604

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

Active Ingredient: FENOPROFEN CALCIUM
Proprietary Name: NALFON
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017604
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: XSPIRE PHARMA
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: FENOPROFEN CALCIUM
Proprietary Name: NALFON
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N017604
Product Number: 004
Approval Date: Jul 21, 2009
Applicant Holder Full Name: XSPIRE PHARMA
Marketing Status:  Prescription
Patent and Exclusivity Information

NALFON (FENOPROFEN CALCIUM)
EQ 300MG BASE
Marketing Status: Discontinued

Active Ingredient: FENOPROFEN CALCIUM
Proprietary Name: NALFON
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N017604
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: XSPIRE PHARMA
Marketing Status:  Discontinued
Patent and Exclusivity Information