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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077152

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TERBUTALINE SULFATE (TERBUTALINE SULFATE)
2.5MG
Marketing Status: Prescription
Active Ingredient: TERBUTALINE SULFATE
Proprietary Name: TERBUTALINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077152
Product Number: 001
Approval Date: Mar 25, 2005
Applicant Holder Full Name: LANNETT CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TERBUTALINE SULFATE (TERBUTALINE SULFATE)
5MG
Marketing Status: Prescription
Active Ingredient: TERBUTALINE SULFATE
Proprietary Name: TERBUTALINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A077152
Product Number: 002
Approval Date: Mar 25, 2005
Applicant Holder Full Name: LANNETT CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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