Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019854
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEPEN PENICILLAMINE 250MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/08/1978 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
08/17/1994 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1993 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1990 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1988 SUPPL-3 Labeling

Label is not available on this site.

11/10/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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