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Generated: November 15, 2018

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Details for New Drug Application (NDA): 020458

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NDA 020458 describes GALZIN, which is a drug marketed by Teva and is included in one NDA. It is available from one supplier. Additional details are available on the GALZIN profile page.

The generic ingredient in GALZIN is zinc acetate. There are thirty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the zinc acetate profile page.
Summary for 020458
Tradename:GALZIN
Applicant:Teva
Ingredient:zinc acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020458
Suppliers and Packaging for NDA: 020458
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALZIN zinc acetate CAPSULE;ORAL 020458 NDA Teva Select Brands 57844-208 57844-208-52 250 CAPSULE in 1 BOTTLE (57844-208-52)
GALZIN zinc acetate CAPSULE;ORAL 020458 NDA Teva Select Brands 57844-215 57844-215-52 250 CAPSULE in 1 BOTTLE (57844-215-52)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG ZINC
Approval Date:Jan 28, 1997TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG ZINC
Approval Date:Jan 28, 1997TE:RLD:Yes

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