Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040306
Company: LANNETT CO INC

• Other Important Information from FDA

Products on ANDA 040306

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040306

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40306_Metadate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40306LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/040306_metadate_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/25/2021	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/09/2021	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/09/2021	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-15	Labeling		Label is not available on this site.
01/21/2016	SUPPL-14	Labeling		Label is not available on this site.
01/21/2016	SUPPL-13	Labeling		Label is not available on this site.
01/21/2016	SUPPL-11	Labeling		Label is not available on this site.
01/21/2016	SUPPL-10	Labeling		Label is not available on this site.
01/21/2016	SUPPL-9	Labeling		Label is not available on this site.
12/28/2005	SUPPL-8	Labeling		Label is not available on this site.
12/09/2002	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/09/2002	SUPPL-2	Labeling		Label is not available on this site.
05/01/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 040306

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40306_Metadate_Prntlbl.pdf