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Details for New Drug Application (NDA): 019961

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NDA 019961 describes GANITE, which is a drug marketed by Chapter 7 Trustee and is included in one NDA. It is available from one supplier. Additional details are available on the GANITE profile page.

The generic ingredient in GANITE is gallium nitrate. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gallium nitrate profile page.

Summary for NDA: 019961

Tradename:
GANITE
Applicant:
Chapter 7 Trustee
Ingredient:
gallium nitrate
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019961

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANITE
gallium nitrate
INJECTABLE;INJECTION 019961 NDA Genta Incorporated 66657-301 66657-301-05 5 VIAL, SINGLE-USE in 1 CARTON (66657-301-05) > 20 mL in 1 VIAL, SINGLE-USE (66657-301-01) (66657-301-01)

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 17, 1991TE:RLD:No

Expired Orange Book Patents for NDA: 019961

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chapter 7 Trustee
GANITE
gallium nitrate
INJECTABLE;INJECTION019961-002Jan 17, 19914,529,593► subscribe
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