Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040300
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/27/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-300_Methylphenidate%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40300ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040300_methylphenidate_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/2016 SUPPL-18 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

10/28/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/20/2015 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/21/2014 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

12/19/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/10/2010 SUPPL-7 Labeling

Label is not available on this site.

03/02/2006 SUPPL-6 Labeling

Label is not available on this site.

04/24/2003 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/27/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-300_Methylphenidate%20Hydrochloride_Prntlbl.pdf

METHYLPHENIDATE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 206932 ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 040220 ACTAVIS LABS FL INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207416 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 209276 AUROLIFE PHARMA LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 209753 BIONPHARMA INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207587 BRECKENRIDGE PHARM
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 208737 CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091159 MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207884 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202892 OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 040300 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090710 SUN PHARM INDS INC
RITALIN METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 010187 NOVARTIS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 206932 ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 040220 ACTAVIS LABS FL INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207416 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209276 AUROLIFE PHARMA LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209753 BIONPHARMA INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207587 BRECKENRIDGE PHARM
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208737 CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 091159 MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207884 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202892 OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 040300 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090710 SUN PHARM INDS INC
RITALIN METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 010187 NOVARTIS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 206932 ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040220 ACTAVIS LABS FL INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 207416 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 209276 AUROLIFE PHARMA LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 209753 BIONPHARMA INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 207587 BRECKENRIDGE PHARM
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208737 CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 091159 MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 207884 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 202892 OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040300 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 090710 SUN PHARM INDS INC
RITALIN METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription Yes AB 010187 NOVARTIS

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