Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091159
Company: MOUNTAIN

Products on ANDA 091159

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Discontinued	None	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091159

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/2014	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
01/15/2026	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
01/15/2026	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
01/15/2026	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
01/15/2026	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/15/2026	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/15/2026	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/15/2026	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
01/15/2026	SUPPL-1	Labeling-Package Insert		Label is not available on this site.