Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075629
Company: SPECGX LLC

• Other Important Information from FDA

Products on ANDA 075629

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLIN ER	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
METHYLIN ER	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075629

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75629ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-629_Mythylphenidate%20Hydrochloride.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/25/2021	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
06/14/2021	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
06/14/2021	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
10/28/2016	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/28/2016	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/20/2015	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/21/2014	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/19/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/10/2010	SUPPL-7	Labeling		Label is not available on this site.
04/24/2003	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075629

METHYLIN ER

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLIN ER	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075629	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207488	ABHAI LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210992	GRANULES

TABLET, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLIN ER	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075629	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207488	ABHAI LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212288	ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210992	GRANULES