Product Details for ANDA 078957
STAVUDINE (STAVUDINE)
15MG
Marketing Status: Discontinued
20MG
Marketing Status: Discontinued
30MG
Marketing Status: Discontinued
40MG
Marketing Status: Discontinued
15MG
Marketing Status: Discontinued
Active Ingredient: STAVUDINE
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078957
Product Number: 001
Approval Date: Dec 29, 2008
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status: Discontinued
Patent and Exclusivity Information
STAVUDINE (STAVUDINE)
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078957
Product Number: 001
Approval Date: Dec 29, 2008
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG
Marketing Status: Discontinued
Active Ingredient: STAVUDINE
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078957
Product Number: 002
Approval Date: Dec 29, 2008
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status: Discontinued
Patent and Exclusivity Information
STAVUDINE (STAVUDINE)
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078957
Product Number: 002
Approval Date: Dec 29, 2008
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status: Discontinued
Patent and Exclusivity Information
30MG
Marketing Status: Discontinued
Active Ingredient: STAVUDINE
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078957
Product Number: 003
Approval Date: Dec 29, 2008
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status: Discontinued
Patent and Exclusivity Information
STAVUDINE (STAVUDINE)
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078957
Product Number: 003
Approval Date: Dec 29, 2008
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status: Discontinued
Patent and Exclusivity Information
40MG
Marketing Status: Discontinued
Active Ingredient: STAVUDINE
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078957
Product Number: 004
Approval Date: Dec 29, 2008
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: STAVUDINE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078957
Product Number: 004
Approval Date: Dec 29, 2008
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status: Discontinued
Patent and Exclusivity Information