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Last Updated: May 27, 2024

Details for New Drug Application (NDA): 019854

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NDA 019854 describes DEPEN, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. Additional details are available on the DEPEN profile page.

The generic ingredient in DEPEN 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 019854
Applicant:Mylan Speciality Lp
Formulation / Manufacturing:see details
Pharmacology for NDA: 019854
Medical Subject Heading (MeSH) Categories for 019854
Suppliers and Packaging for NDA: 019854
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEPEN penicillamine TABLET;ORAL 019854 NDA Meda Pharmaceuticals Inc. 0037-4401 0037-4401-01 100 TABLET in 1 BOTTLE (0037-4401-01)

Profile for product number 001

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

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