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Details for New Drug Application (NDA): 020412

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NDA 020412 describes ZERIT, which is a drug marketed by Bristol Myers Squibb and is included in three NDAs. It is available from two suppliers. There is one patent protecting this drug. 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. Nine suppliers are listed for this compound. There are fourteen tentative approvals for this compound. Additional details are available on the stavudine profile page.

Summary for NDA: 020412

Tradename:
ZERIT
Applicant:
Bristol Myers Squibb
Ingredient:
stavudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 020412

Suppliers and Packaging for NDA: 020412

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZERIT
stavudine
CAPSULE;ORAL 020412 NDA E.R. Squibb & Sons, L.L.C. 0003-1964 0003-1964-01 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0003-1964-01)
ZERIT
stavudine
CAPSULE;ORAL 020412 NDA E.R. Squibb & Sons, L.L.C. 0003-1965 0003-1965-01 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0003-1965-01)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Jun 24, 1994TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Jun 24, 1994TE:ABRLD:No

Expired Orange Book Patents for NDA: 020412

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
ZERIT
stavudine
CAPSULE;ORAL020412-001Jun 24, 19944,978,655*PED► subscribe
Bristol Myers Squibb
ZERIT
stavudine
CAPSULE;ORAL020412-005Jun 24, 19944,978,655*PED► subscribe
Bristol Myers Squibb
ZERIT
stavudine
CAPSULE;ORAL020412-004Jun 24, 19944,978,655*PED► subscribe
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