Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020412

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ZERIT (STAVUDINE)
5MG
Marketing Status: Discontinued

Active Ingredient: STAVUDINE
Proprietary Name: ZERIT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020412
Product Number: 001
Approval Date: Jun 24, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

ZERIT (STAVUDINE)
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: STAVUDINE
Proprietary Name: ZERIT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020412
Product Number: 002
Approval Date: Jun 24, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

ZERIT (STAVUDINE)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: STAVUDINE
Proprietary Name: ZERIT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020412
Product Number: 003
Approval Date: Jun 24, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

ZERIT (STAVUDINE)
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: STAVUDINE
Proprietary Name: ZERIT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020412
Product Number: 004
Approval Date: Jun 24, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

ZERIT (STAVUDINE)
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: STAVUDINE
Proprietary Name: ZERIT
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020412
Product Number: 005
Approval Date: Jun 24, 1994
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information