Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021259
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 Yes No
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 Yes No
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 Yes No
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 Yes No
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 Yes No
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB2 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
04/03/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21259lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-259_Metadate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-259_Metadate.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021259s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021259Orig1s030ltr.pdf
04/17/2015 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021259s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021259Orig1s029ltr.pdf
06/15/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/13/2013 SUPPL-27 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s027ltr.pdf
06/04/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s026ltr.pdf
05/06/2013 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s023,s024ltr.pdf
05/06/2013 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021259Orig1s023,s024ltr.pdf
10/18/2010 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021259s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021259s022ltr.pdf
04/16/2009 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021259s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021259s021ltr.pdf
05/04/2007 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021259s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021259s020ltr.pdf
08/26/2008 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021259s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021259s019ltr.pdf
08/10/2006 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021259s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021259s018LTR.pdf
02/19/2006 SUPPL-17 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021259s017ltr.pdf
09/22/2003 SUPPL-8 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21259scm008ltr.pdf
06/19/2003 SUPPL-6 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21259scm006ltr.pdf
05/27/2003 SUPPL-5 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21259scm005ltr.pdf
11/06/2002 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/18/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/09/2002 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21259s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21259s1ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/04/2017 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021259s030lbl.pdf
04/17/2015 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021259s029lbl.pdf
12/13/2013 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s027lbl.pdf
12/13/2013 SUPPL-27 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s027lbl.pdf
06/04/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s026lbl.pdf
05/06/2013 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s024lbl.pdf
05/06/2013 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s023lbl.pdf
10/18/2010 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021259s022lbl.pdf
04/16/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021259s021lbl.pdf
08/26/2008 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021259s019lbl.pdf
05/04/2007 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021259s020lbl.pdf
08/10/2006 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021259s018lbl.pdf
04/09/2002 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21259s1lbl.pdf
04/03/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21259lbl.pdf

METADATE CD

CAPSULE, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB2 021259 LANNETT CO INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 205105 IMPAX LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 203583 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 077707 TEVA PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB2 021259 LANNETT CO INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 205105 IMPAX LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 203583 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 077707 TEVA PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB2 021259 LANNETT CO INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 205105 IMPAX LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 203583 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 077707 TEVA PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB2 021259 LANNETT CO INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 205105 IMPAX LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 203583 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 078873 TEVA PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB2 021259 LANNETT CO INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 205105 IMPAX LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 203583 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 078873 TEVA PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METADATE CD METHYLPHENIDATE HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB2 021259 LANNETT CO INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 205105 IMPAX LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 203583 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB2 078873 TEVA PHARMS

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