APPLICATION
ANDA085799
TYPE
ANDA
ORIGINAL APPROVAL
1977-12-23
LATEST ACTION
2016-01-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2016-01-21Labeling · Supplement 43AP
2016-01-21Labeling · Supplement 41AP
2016-01-21Labeling · Supplement 38AP
2016-01-21Labeling · Supplement 44AP
2016-01-21Labeling · Supplement 42AP
2016-01-21Labeling · Supplement 39AP
2016-01-21Labeling · Supplement 45 · standardAP
2016-01-21Labeling · Supplement 37AP
2005-12-28Labeling · Supplement 36AP
2004-07-19Labeling · Supplement 35AP
2002-12-09Manufacturing (CMC) · Supplement 32AP
2002-10-09Labeling · Supplement 31AP
1999-11-08Labeling · Supplement 30AP
1998-11-24Manufacturing (CMC) · Supplement 27AP
1998-11-24Manufacturing (CMC) · Supplement 25AP
1998-11-24Manufacturing (CMC) · Supplement 26AP
1998-11-24Manufacturing (CMC) · Supplement 24AP
1998-02-13Labeling · Supplement 23AP
1996-07-02Labeling · Supplement 22AP
1995-06-30Manufacturing (CMC) · Supplement 21AP
1995-05-24Manufacturing (CMC) · Supplement 20AP
1992-01-24Bioequivalence · Supplement 19AP
1989-05-10Labeling · Supplement 17AP
1984-12-10Manufacturing (CMC) · Supplement 13AP
1984-12-10Manufacturing (CMC) · Supplement 14AP
1977-12-23OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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