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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213310
Company: APOTEX

Products on ANDA 213310

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENICILLAMINE	PENICILLAMINE	250MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213310

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213310

PENICILLAMINE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CUPRIMINE	PENICILLAMINE	250MG	CAPSULE;ORAL	Prescription	Yes	AB	019853	VALEANT PHARMS INTL
PENICILLAMINE	PENICILLAMINE	250MG	CAPSULE;ORAL	Prescription	No	AB	213310	APOTEX
PENICILLAMINE	PENICILLAMINE	250MG	CAPSULE;ORAL	Prescription	No	AB	215409	BRECKENRIDGE
PENICILLAMINE	PENICILLAMINE	250MG	CAPSULE;ORAL	Prescription	No	AB	211867	DR REDDYS
PENICILLAMINE	PENICILLAMINE	250MG	CAPSULE;ORAL	Prescription	No	AB	211231	ENDO OPERATIONS
PENICILLAMINE	PENICILLAMINE	250MG	CAPSULE;ORAL	Prescription	No	AB	211735	GRANULES
PENICILLAMINE	PENICILLAMINE	250MG	CAPSULE;ORAL	Prescription	No	AB	213293	INVAGEN PHARMS
PENICILLAMINE	PENICILLAMINE	250MG	CAPSULE;ORAL	Prescription	No	AB	214363	NAVINTA LLC
PENICILLAMINE	PENICILLAMINE	250MG	CAPSULE;ORAL	Prescription	No	AB	210976	WATSON LABS INC

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