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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212933

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NDA 212933 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 212933

Tradename:	PENICILLAMINE
Applicant:	Lupin Ltd
Ingredient:	penicillamine
Patents:	0

Pharmacology for NDA: 212933

Medical Subject Heading (MeSH) Categories for 212933

Antidotes
Antirheumatic Agents
Chelating Agents

Suppliers and Packaging for NDA: 212933

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PENICILLAMINE	penicillamine	TABLET;ORAL	212933	ANDA	Lupin Pharmaceuticals, Inc.	70748-153	70748-153-01	100 TABLET in 1 BOTTLE (70748-153-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Nov 30, 2020	TE:	AB	RLD:	No

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