Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202608
Company: SPECGX LLC

Products on ANDA 202608

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	BX	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	BX	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	BX	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202608

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/2012	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202608Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202608Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2016	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/28/2016	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/28/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202608

METHYLPHENIDATE HYDROCHLORIDE

There are no Therapeutic Equivalents.