Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010187
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RITALIN METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB Yes No
RITALIN METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB Yes No
RITALIN METHYLPHENIDATE HYDROCHLORIDE 20MG 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
12/05/1955 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-87 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010187s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/010187Orig1s087,018029Orig1s055,021284Orig1s034ltr.pdf
05/27/2016 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

01/10/2019 SUPPL-82 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010187Orig1s071s082,018029Oirg1s041s051,021284Oirg1s016s029ltr.pdf
10/02/2015 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

04/17/2015 SUPPL-80 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010187Orig1s080,018029Orig1s049,021284Orig1s027ltr.pdf
07/14/2014 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

12/13/2013 SUPPL-77 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s077,018029Orig1s047,021284Orig1s023ltr.pdf
02/07/2014 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

10/25/2013 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

06/07/2013 SUPPL-74 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s074,018029Orig1s044,021284Orig1s019ltr.pdf
12/09/2010 SUPPL-73 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf
11/15/2010 SUPPL-72 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010187s072,018029s042,021284s017ltr.pdf
01/10/2019 SUPPL-71 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010187Orig1s071s082,018029Oirg1s041s051,021284Oirg1s016s029ltr.pdf
04/25/2007 SUPPL-69 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010187s069,018029s040,021284s011ltr.pdf
08/08/2006 SUPPL-67 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf
08/08/2006 SUPPL-66 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf
06/12/2002 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/2002 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

01/11/2002 SUPPL-60 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10187s60ltr.pdf
08/15/2001 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/2004 SUPPL-58 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf
05/21/2004 SUPPL-57 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf
01/11/2000 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

04/13/1999 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/24/1998 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

09/17/1998 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

08/12/1998 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1998 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/1998 SUPPL-50 Labeling

Label is not available on this site.

07/09/1997 SUPPL-48 Labeling

Label is not available on this site.

12/15/1995 SUPPL-47 Labeling

Label is not available on this site.

07/09/1997 SUPPL-46 Labeling

Label is not available on this site.

06/01/1995 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

08/19/1994 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

05/31/1994 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1997 SUPPL-42 Labeling

Label is not available on this site.

03/07/1994 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1990 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

07/09/1997 SUPPL-39 Labeling

Label is not available on this site.

12/08/1987 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1986 SUPPL-37 Labeling

Label is not available on this site.

03/13/1985 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1985 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1981 SUPPL-32 Labeling

Label is not available on this site.

03/06/1980 SUPPL-31 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/15/1980 SUPPL-30 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/09/1975 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1979 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1975 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1975 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1975 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1975 SUPPL-21 Manufacturing (CMC)-Control

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-82 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf
01/10/2019 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf
01/04/2017 SUPPL-87 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010187s087lbl.pdf
04/17/2015 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf
12/13/2013 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf
12/13/2013 SUPPL-77 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf
06/07/2013 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.pdf
12/09/2010 SUPPL-73 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s073lbl.pdf
11/15/2010 SUPPL-72 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.pdf
04/25/2007 SUPPL-69 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf
08/08/2006 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf
08/08/2006 SUPPL-66 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf

RITALIN

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 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 086429 LANNETT CO INC
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 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 085799 LANNETT CO INC
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 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 086428 LANNETT CO INC
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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