Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021278
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription AB Yes No
FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB Yes No
FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/13/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021278s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021278Orig1s023,021802Orig1s033ltr.pdf
05/13/2016 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/04/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/10/2019 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s011s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021278Orig1s011s019,021802Oirg1s019s029ltr.pdf
04/17/2015 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021278s018,021802s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021278Orig1s018,021802Orig1s028ltr.pdf
12/12/2013 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021278Orig1s017,021802Orig1s026ltr.pdf
06/11/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021802Orig1s025,021278Orig1s016ltr.pdf
05/02/2012 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021278s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021802s024,021278s015ltr.pdf
12/09/2010 SUPPL-13 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf
11/15/2010 SUPPL-12 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s021,021278s012ltr.pdf
01/10/2019 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s011s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021278Orig1s011s019,021802Oirg1s019s029ltr.pdf
04/25/2007 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s008,021802s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021278s008,021802s009ltr.pdf
03/08/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021278s007ltr.pdf
08/24/2006 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021278s004, s005ltr.pdf
08/24/2006 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021278s004, s005ltr.pdf
01/03/2002 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
01/10/2019 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s011s019lbl.pdf
01/10/2019 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s011s019lbl.pdf
01/04/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021278s023lbl.pdf
04/17/2015 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021278s018,021802s028lbl.pdf
12/12/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s017lbl.pdf
12/12/2013 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s017lbl.pdf
06/11/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021278s016lbl.pdf
05/02/2012 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021278s015lbl.pdf
12/09/2010 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s013lbl.pdf
12/09/2010 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s013lbl.pdf
11/15/2010 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s012lbl.pdf
11/15/2010 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021278s012lbl.pdf
04/25/2007 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s008,021802s009lbl.pdf
03/08/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s007lbl.pdf
08/24/2006 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf
08/24/2006 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021278s004_005lbl.pdf
11/13/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-278_Focalin_prntlbl.pdf

FOCALIN

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 206931 ABHAI INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 212631 ALKEM LABS LTD
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 209468 LANNETT CO INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 204534 NOVEL LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 208756 RHODES PHARMS
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 201231 SUN PHARM INDUSTRIES
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription No AB 207901 TRIS PHARMA INC
FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET;ORAL Prescription Yes AB 021278 NOVARTIS

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 206931 ABHAI INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 212631 ALKEM LABS LTD
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 209211 CEDIPROF INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 209468 LANNETT CO INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 204534 NOVEL LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 208756 RHODES PHARMS
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 201231 SUN PHARM INDUSTRIES
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207901 TRIS PHARMA INC
FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 021278 NOVARTIS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 206931 ABHAI INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 212631 ALKEM LABS LTD
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209211 CEDIPROF INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209468 LANNETT CO INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 204534 NOVEL LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208756 RHODES PHARMS
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 201231 SUN PHARM INDUSTRIES
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207901 TRIS PHARMA INC
FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 021278 NOVARTIS

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