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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 020412


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NDA 020412 describes ZERIT, which is a drug marketed by Bristol and Bristol Myers Squibb and is included in three NDAs. Additional details are available on the ZERIT profile page.

The generic ingredient in ZERIT is stavudine. There are fourteen drug master file entries for this compound. Additional details are available on the stavudine profile page.
Summary for 020412
Tradename:ZERIT
Applicant:Bristol
Ingredient:stavudine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020412

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 24, 1994TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 24, 1994TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 24, 1994TE:RLD:Yes

Expired US Patents for NDA 020412

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol ZERIT stavudine CAPSULE;ORAL 020412-001 Jun 24, 1994 ⤷  Try a Trial ⤷  Try a Trial
Bristol ZERIT stavudine CAPSULE;ORAL 020412-005 Jun 24, 1994 ⤷  Try a Trial ⤷  Try a Trial
Bristol ZERIT stavudine CAPSULE;ORAL 020412-004 Jun 24, 1994 ⤷  Try a Trial ⤷  Try a Trial
Bristol ZERIT stavudine CAPSULE;ORAL 020412-002 Jun 24, 1994 ⤷  Try a Trial ⤷  Try a Trial
Bristol ZERIT stavudine CAPSULE;ORAL 020412-003 Jun 24, 1994 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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