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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 210976

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NDA 210976 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 210976

Tradename:	PENICILLAMINE
Applicant:	Watson Labs Inc
Ingredient:	penicillamine
Patents:	0

Pharmacology for NDA: 210976

Medical Subject Heading (MeSH) Categories for 210976

Antidotes
Antirheumatic Agents
Chelating Agents

Suppliers and Packaging for NDA: 210976

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PENICILLAMINE	penicillamine	CAPSULE;ORAL	210976	ANDA	Actavis Pharma, Inc.	0591-4171	0591-4171-01	100 CAPSULE in 1 BOTTLE (0591-4171-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Jun 24, 2019	TE:	AB	RLD:	No

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