Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017849

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BRETHINE (TERBUTALINE SULFATE)
2.5MG
Marketing Status: Prescription
Active Ingredient: TERBUTALINE SULFATE
Proprietary Name: BRETHINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017849
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
BRETHINE (TERBUTALINE SULFATE)
5MG
Marketing Status: Prescription
Active Ingredient: TERBUTALINE SULFATE
Proprietary Name: BRETHINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017849
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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