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Generated: April 30, 2017

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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

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019961

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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
gallium nitrate
INJECTABLE;INJECTION019961-002Jan 17, 19914,529,593► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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