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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 211196

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NDA 211196 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 211196

Tradename:	PENICILLAMINE
Applicant:	Endo Operations
Ingredient:	penicillamine
Patents:	0

Pharmacology for NDA: 211196

Medical Subject Heading (MeSH) Categories for 211196

Antidotes
Antirheumatic Agents
Chelating Agents

Suppliers and Packaging for NDA: 211196

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PENICILLAMINE	penicillamine	TABLET;ORAL	211196	ANDA	Endo USA, Inc.	0254-2000	0254-2000-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2000-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Dec 23, 2019	TE:	AB	RLD:	No

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