Drugs@FDA: FDA Approved Drug Products

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

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

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 AMERIGEN PHARMS LTD
PENICILLAMINE PENICILLAMINE 250MG CAPSULE;ORAL Prescription No AB 210976 WATSON LABS INC

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