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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019853
Company: VALEANT PHARMS INTL

Products on NDA 019853

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CUPRIMINE	PENICILLAMINE	250MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes
CUPRIMINE	PENICILLAMINE	125MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019853

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/1970	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2004	SUPPL-14	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19853s012,014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019853Orig1S014.pdf
05/27/2003	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19853slr013_cuprimine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr013ltr.pdf
10/26/2004	SUPPL-12	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19853s012,014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019853Orig1s012.pdf
11/20/2003	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr007,011ltr.pdf
03/01/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/18/1994	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
11/20/2003	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr007,011ltr.pdf
10/04/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/09/1989	SUPPL-4	Labeling		Label is not available on this site.
01/05/1989	SUPPL-3	Labeling		Label is not available on this site.
08/25/1987	SUPPL-2	Labeling		Label is not available on this site.
08/21/1987	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

Labels for NDA 019853

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2004	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf
10/26/2004	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf
05/27/2003	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19853slr013_cuprimine_lbl.pdf

Therapeutic Equivalents for NDA 019853

CUPRIMINE

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	209921	ANI PHARMS
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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