Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085799
Company: LANNETT CO INC

Products on ANDA 085799

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085799

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/1977	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/21/2016	SUPPL-45	Labeling-Medication Guide		Label is not available on this site.
01/21/2016	SUPPL-44	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-43	Labeling		Label is not available on this site.
01/21/2016	SUPPL-42	Labeling		Label is not available on this site.
01/21/2016	SUPPL-41	Labeling		Label is not available on this site.
01/21/2016	SUPPL-39	Labeling		Label is not available on this site.
01/21/2016	SUPPL-38	Labeling		Label is not available on this site.
01/21/2016	SUPPL-37	Labeling		Label is not available on this site.
12/28/2005	SUPPL-36	Labeling		Label is not available on this site.
07/19/2004	SUPPL-35	Labeling		Label is not available on this site.
12/09/2002	SUPPL-32	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/09/2002	SUPPL-31	Labeling		Label is not available on this site.
11/08/1999	SUPPL-30	Labeling		Label is not available on this site.
11/24/1998	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
11/24/1998	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
11/24/1998	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
11/24/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
02/13/1998	SUPPL-23	Labeling		Label is not available on this site.
07/02/1996	SUPPL-22	Labeling		Label is not available on this site.
06/30/1995	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
05/24/1995	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
01/24/1992	SUPPL-19	Bioequivalence		Label is not available on this site.
05/10/1989	SUPPL-17	Labeling		Label is not available on this site.
12/10/1984	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/10/1984	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.