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Last Updated: June 21, 2024

Details for New Drug Application (NDA): 019853

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NDA 019853 describes CUPRIMINE, which is a drug marketed by Valeant Pharms Intl and is included in one NDA. It is available from two suppliers. Additional details are available on the CUPRIMINE profile page.

The generic ingredient in CUPRIMINE is penicillamine. There are eighteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the penicillamine profile page.
Summary for 019853
Applicant:Valeant Pharms Intl
Formulation / Manufacturing:see details
Pharmacology for NDA: 019853
Medical Subject Heading (MeSH) Categories for 019853
Suppliers and Packaging for NDA: 019853
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CUPRIMINE penicillamine CAPSULE;ORAL 019853 NDA Bausch Health US, LLC 25010-705 25010-705-15 100 CAPSULE in 1 BOTTLE (25010-705-15)
CUPRIMINE penicillamine CAPSULE;ORAL 019853 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-020 68682-020-10 100 CAPSULE in 1 BOTTLE (68682-020-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength125MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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