Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021453

Expand all

ZERIT XR (STAVUDINE)
37.5MG
Marketing Status: Discontinued
Active Ingredient: STAVUDINE
Proprietary Name: ZERIT XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 37.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021453
Product Number: 001
Approval Date: Dec 31, 2002
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
ZERIT XR (STAVUDINE)
50MG
Marketing Status: Discontinued
Active Ingredient: STAVUDINE
Proprietary Name: ZERIT XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021453
Product Number: 002
Approval Date: Dec 31, 2002
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
ZERIT XR (STAVUDINE)
75MG
Marketing Status: Discontinued
Active Ingredient: STAVUDINE
Proprietary Name: ZERIT XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021453
Product Number: 003
Approval Date: Dec 31, 2002
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
ZERIT XR (STAVUDINE)
100MG
Marketing Status: Discontinued
Active Ingredient: STAVUDINE
Proprietary Name: ZERIT XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021453
Product Number: 004
Approval Date: Dec 31, 2002
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English