Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021259
Company: AYTU BIOPHARMA
Company: AYTU BIOPHARMA
| 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 |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021259s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021259Orig1s034ltr.pdf | |
| 06/25/2021 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021259s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021259Orig1s032ltr.pdf | |
| 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-Medication Guide, Labeling-Package Insert |
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 | |
| 04/22/2022 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021259s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021259Orig1s025ltr.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-Container/Carton Labels, Labeling-Package Insert |
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 |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021259s034lbl.pdf | |
| 04/22/2022 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021259s025lbl.pdf | |
| 06/25/2021 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021259s032lbl.pdf | |
| 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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021259s027lbl.pdf | |
| 12/13/2013 | SUPPL-27 | Labeling-Package Insert | 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 | AYTU BIOPHARMA |
| 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 | AYTU BIOPHARMA |
| 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 | AYTU BIOPHARMA |
| 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 | AYTU BIOPHARMA |
| 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 | AYTU BIOPHARMA |
| 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 | AYTU BIOPHARMA |
| 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 |