Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 087943

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THEO-24 (THEOPHYLLINE)
100MG
Marketing Status: Prescription

Active Ingredient: THEOPHYLLINE
Proprietary Name: THEO-24
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A087943
Product Number: 002
Approval Date: Aug 22, 1983
Applicant Holder Full Name: AUXILIUM PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

THEO-24 (THEOPHYLLINE)
200MG
Marketing Status: Prescription

Active Ingredient: THEOPHYLLINE
Proprietary Name: THEO-24
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: A087943
Product Number: 001
Approval Date: Aug 22, 1983
Applicant Holder Full Name: AUXILIUM PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

THEO-24 (THEOPHYLLINE)
300MG
Marketing Status: Prescription

Active Ingredient: THEOPHYLLINE
Proprietary Name: THEO-24
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A087943
Product Number: 003
Approval Date: Aug 22, 1983
Applicant Holder Full Name: AUXILIUM PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

THEO-24 (THEOPHYLLINE)
400MG
Marketing Status: Prescription

Active Ingredient: THEOPHYLLINE
Proprietary Name: THEO-24
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A087943
Product Number: 004
Approval Date: Feb 28, 1992
Applicant Holder Full Name: AUXILIUM PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information