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Last Updated: September 24, 2020

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Details for New Drug Application (NDA): 021453

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NDA 021453 describes ZERIT XR, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. There is one patent protecting this drug. Additional details are available on the ZERIT XR profile page.

The generic ingredient in ZERIT XR is stavudine. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the stavudine profile page.
Summary for 021453
Tradename:ZERIT XR
Applicant:Bristol Myers Squibb
Ingredient:stavudine
Patents:1
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021453

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength37.5MG
Approval Date:Dec 31, 2002TE:RLD:No
Patent:  Start TrialPatent Expiration:Aug 18, 2023Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength50MG
Approval Date:Dec 31, 2002TE:RLD:No
Patent:  Start TrialPatent Expiration:Aug 18, 2023Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength75MG
Approval Date:Dec 31, 2002TE:RLD:No
Patent:  Start TrialPatent Expiration:Aug 18, 2023Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021453

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-001 Dec 31, 2002   Start Trial   Start Trial
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-004 Dec 31, 2002   Start Trial   Start Trial
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-003 Dec 31, 2002   Start Trial   Start Trial
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-002 Dec 31, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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