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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 214363

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NDA 214363 describes PENICILLAMINE, which is a drug marketed by Apotex, Breckenridge, Dr Reddys, Endo Operations, Granules, Invagen Pharms, Navinta Llc, Watson Labs Inc, Lupin Ltd, and Teva Pharms Usa, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the PENICILLAMINE profile page.

The generic ingredient in PENICILLAMINE 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 214363

Tradename:	PENICILLAMINE
Applicant:	Navinta Llc
Ingredient:	penicillamine
Patents:	0

Pharmacology for NDA: 214363

Medical Subject Heading (MeSH) Categories for 214363

Antidotes
Antirheumatic Agents
Chelating Agents

Suppliers and Packaging for NDA: 214363

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PENICILLAMINE	penicillamine	CAPSULE;ORAL	214363	ANDA	Navinta LLC	68475-201	68475-201-01	100 CAPSULE in 1 BOTTLE (68475-201-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Oct 8, 2021	TE:	AB	RLD:	No

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