Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019854
Company: MYLAN SPECIALITY LP

Products on NDA 019854

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEPEN	PENICILLAMINE	250MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019854

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.

Therapeutic Equivalents for NDA 019854

DEPEN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEPEN	PENICILLAMINE	250MG	TABLET;ORAL	Prescription	Yes	AB	019854	MYLAN SPECIALITY LP
PENICILLAMINE	PENICILLAMINE	250MG	TABLET;ORAL	Prescription	No	AB	212933	LUPIN LTD
PENICILLAMINE	PENICILLAMINE	250MG	TABLET;ORAL	Prescription	No	AB	211196	PAR PHARM INC