Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021802
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes 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
05/26/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021802lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021802ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021802s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021802s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021278Orig1s023,021802Orig1s033ltr.pdf
12/04/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/10/2019 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s019s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021278Orig1s011s019,021802Oirg1s019s029ltr.pdf
04/17/2015 SUPPL-28 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
06/12/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021278Orig1s017,021802Orig1s026ltr.pdf
06/11/2013 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021802Orig1s025,021278Orig1s016ltr.pdf
05/02/2012 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021802s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021802s024,021278s015ltr.pdf
04/21/2011 SUPPL-22 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021802s022lbl.pdf
11/15/2010 SUPPL-21 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s021,021278s012ltr.pdf
01/10/2019 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s019s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021278Orig1s011s019,021802Oirg1s019s029ltr.pdf
05/04/2010 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021802s017ltr.pdf
10/23/2009 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021802s016ltr.pdf021802s014,s016ltr.pdf
10/23/2009 SUPPL-14 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021802s014,s016ltr.pdf
10/17/2008 SUPPL-12 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021802s012ltr.pdf
04/25/2007 SUPPL-9 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
08/01/2006 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s007, s003LTR.pdf
04/11/2006 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s001, s005ltr.pdf
08/01/2006 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s007, s003LTR.pdf
04/11/2006 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021802s001, s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/10/2019 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s019s029lbl.pdf
01/10/2019 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s019s029lbl.pdf
01/04/2017 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021802s033lbl.pdf
04/17/2015 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021278s018,021802s028lbl.pdf
12/12/2013 SUPPL-26 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s026lbl.pdf
12/12/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s026lbl.pdf
06/11/2013 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021802s025lbl.pdf
05/02/2012 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021802s024lbl.pdf
04/21/2011 SUPPL-22 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021802s022lbl.pdf
11/15/2010 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s021lbl.pdf
11/15/2010 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s021lbl.pdf
05/04/2010 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021802s017lbl.pdf
10/23/2009 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf
10/23/2009 SUPPL-14 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021802s014s016lbl.pdf
04/25/2007 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021278s008,021802s009lbl.pdf
08/01/2006 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf
08/01/2006 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf
08/01/2006 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s007s003lbl.pdf
04/11/2006 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf
04/11/2006 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021802s001,s005lbl.pdf
05/26/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021802lbl.pdf

FOCALIN XR

CAPSULE, EXTENDED RELEASE;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 CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210279 ADARE PHARMS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 079108 IMPAX LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204266 MYLAN
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202842 PAR PHARM INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078908 TEVA PHARMS USA
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021802 NOVARTIS

CAPSULE, EXTENDED RELEASE;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 CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210279 ADARE PHARMS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 079108 IMPAX LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204266 MYLAN
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202842 PAR PHARM INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078908 TEVA PHARMS USA
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021802 NOVARTIS

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210279 ADARE PHARMS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 079108 IMPAX LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204266 MYLAN
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202842 PAR PHARM INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078908 TEVA PHARMS USA
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021802 NOVARTIS

CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210279 ADARE PHARMS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 079108 IMPAX LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078992 INTELLIPHARMACEUTICS
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204266 MYLAN
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202842 PAR PHARM INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078908 TEVA PHARMS USA
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021802 NOVARTIS

CAPSULE, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210279 ADARE PHARMS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 079108 IMPAX LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078992 INTELLIPHARMACEUTICS
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202580 MYLAN
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202842 PAR PHARM INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202731 TEVA PHARMS USA
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021802 NOVARTIS

CAPSULE, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210279 ADARE PHARMS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204266 MYLAN
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202842 PAR PHARM INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202731 TEVA PHARMS USA
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021802 NOVARTIS

CAPSULE, EXTENDED RELEASE;ORAL; 35MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210279 ADARE PHARMS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203614 IMPAX LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202842 PAR PHARM INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202731 TEVA PHARMS USA
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021802 NOVARTIS

CAPSULE, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210279 ADARE PHARMS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203614 IMPAX LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202842 PAR PHARM INC
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202731 TEVA PHARMS USA
FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021802 NOVARTIS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English