Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089601
Company: LANNETT CO INC

• Other Important Information from FDA

Products on ANDA 089601

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METADATE ER	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089601

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/1988	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
06/25/2021	SUPPL-36	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/21/2016	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
08/31/2011	SUPPL-29	Labeling		Label is not available on this site.
01/21/2016	SUPPL-28	Labeling		Label is not available on this site.
01/21/2016	SUPPL-27	Labeling		Label is not available on this site.
01/21/2016	SUPPL-25	Labeling		Label is not available on this site.
01/21/2016	SUPPL-24	Labeling		Label is not available on this site.
01/21/2016	SUPPL-23	Labeling		Label is not available on this site.
12/28/2005	SUPPL-22	Labeling		Label is not available on this site.
12/09/2002	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/09/2002	SUPPL-16	Labeling		Label is not available on this site.
10/23/2001	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
11/08/1999	SUPPL-14	Labeling		Label is not available on this site.
10/20/1999	SUPPL-12	Labeling		Label is not available on this site.
02/22/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/08/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/08/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/13/1998	SUPPL-7	Labeling		Label is not available on this site.
07/02/1996	SUPPL-6	Labeling		Label is not available on this site.
09/11/1995	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/25/1994	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/21/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.