Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077672

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STAVUDINE (STAVUDINE)
15MG
Marketing Status: Prescription
Active Ingredient: STAVUDINE
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077672
Product Number: 003
Approval Date: Dec 29, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
STAVUDINE (STAVUDINE)
20MG
Marketing Status: Prescription
Active Ingredient: STAVUDINE
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077672
Product Number: 004
Approval Date: Dec 29, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
STAVUDINE (STAVUDINE)
30MG
Marketing Status: Prescription
Active Ingredient: STAVUDINE
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077672
Product Number: 001
Approval Date: Dec 29, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
STAVUDINE (STAVUDINE)
40MG
Marketing Status: Prescription
Active Ingredient: STAVUDINE
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077672
Product Number: 002
Approval Date: Dec 29, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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