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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021419
Company: SPECGX LLC

Medication Guide

Other Important Information from FDA

Products on NDA 021419

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLIN	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes
METHYLIN	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021419

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21419ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-419_Methylin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021419s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021475Orig1s012; 021419Orig1s023ltr.pdf
06/25/2021	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021419s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021419Orig1s020; 021475Orig1s011ltr.pdf
01/04/2017	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021419s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021419Orig1s014,021475Orig1s010ltr.pdf
07/19/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021419s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021419Orig1s010ltr.pdf
04/17/2015	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021419s009,021475s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021475Orig1s009,021419Orig1s009ltr.pdf
09/15/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/12/2013	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021419s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s007,021475Orig1s007ltr.pdf
06/14/2013	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021419s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021419Orig1s006,021475Orig1s006ltr.pdf
10/18/2010	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021419s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021419s004,021475s005ltr.pdf
08/10/2006	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021475s002,021419s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021475s002, 021419s003LTR.pdf
06/07/2007	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021419s001,021475s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021419s001,021475s004ltr.pdf

Labels for NDA 021419

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/13/2023	SUPPL-23	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021419s023lbl.pdf
10/13/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021419s023lbl.pdf
07/19/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021419s010lbl.pdf
06/25/2021	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021419s020lbl.pdf
01/04/2017	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021419s014lbl.pdf
01/04/2017	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021419s014lbl.pdf
04/17/2015	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021419s009,021475s009lbl.pdf
12/12/2013	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021419s007lbl.pdf
06/14/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021419s006lbl.pdf
10/18/2010	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021419s004lbl.pdf
06/07/2007	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021419s001,021475s004lbl.pdf
08/10/2006	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021475s002,021419s003lbl.pdf

Therapeutic Equivalents for NDA 021419

METHYLIN

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLIN	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	021419	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207485	ABHAI LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211647	ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207417	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204602	NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210764	PATRIN
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	213567	QUAGEN
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	091601	TRIS PHARMA INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210139	WES PHARMA INC

SOLUTION;ORAL; 10MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLIN	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	021419	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207485	ABHAI LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211647	ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207417	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204602	NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210764	PATRIN
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	213567	QUAGEN
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	091601	TRIS PHARMA INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210139	WES PHARMA INC

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