Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 200603
Company: SUNOVION PHARMS INC
Company: SUNOVION PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LATUDA | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| LATUDA | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LATUDA | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LATUDA | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LATUDA | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 10/28/2010 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200603s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/04/2019 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200603s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200603Orig1s035ltr.pdf | |
| 09/25/2017 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s030ltr.pdf | |
| 03/05/2018 | SUPPL-29 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200603s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200603Orig1s029ltr.pdf | |
| 02/23/2017 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s028ltr.pdf | |
| 01/27/2017 | SUPPL-27 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s26s27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s26,s27ltr.pdf | |
| 01/27/2017 | SUPPL-26 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s26s27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s26,s27ltr.pdf | |
| 12/20/2016 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/2016 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/2016 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/2017 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200603Orig1s021ltr.pdf | |
| 07/30/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/2015 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2014 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/2013 | SUPPL-16 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603Org1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Org1s016ltr.pdf | |
| 07/12/2013 | SUPPL-15 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s015lbl.pdf | |
| 05/21/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/2013 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s009,s013ltr.pdf | |
| 06/13/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/2013 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s010,s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s011.pdf | |
| 06/28/2013 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s010,s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200603Orig1s010.pdf | |
| 01/22/2013 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200603Orig1s009,s013ltr.pdf | |
| 04/26/2012 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200603s005,s007ltr.pdf | |
| 12/07/2011 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200603s004,s006ltr.pdf | |
| 04/26/2012 | SUPPL-5 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200603s005,s007ltr.pdf | |
| 12/07/2011 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200603s004,s006ltr.pdf | |
| 12/10/2010 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200603s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/04/2019 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200603s035lbl.pdf | |
| 03/05/2018 | SUPPL-29 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200603s029lbl.pdf | |
| 09/25/2017 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s030lbl.pdf | |
| 02/23/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s028lbl.pdf | |
| 01/27/2017 | SUPPL-27 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s26s27lbl.pdf | |
| 01/27/2017 | SUPPL-26 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s26s27lbl.pdf | |
| 01/11/2017 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200603s021lbl.pdf | |
| 09/03/2013 | SUPPL-16 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603Org1s016lbl.pdf | |
| 07/12/2013 | SUPPL-15 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s015lbl.pdf |
| 06/28/2013 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf | |
| 06/28/2013 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603lbls10s11.pdf | |
| 01/22/2013 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf | |
| 01/22/2013 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200603s009s013lbl.pdf | |
| 04/26/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf | |
| 04/26/2012 | SUPPL-5 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200603s005s007lbl.pdf | |
| 12/07/2011 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf | |
| 12/07/2011 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200603s004s006lbl.pdf | |
| 12/10/2010 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s001lbl.pdf | |
| 10/28/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200603s000lbl.pdf |
LATUDA
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LATUDA | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | Yes | AB | 200603 | SUNOVION PHARMS INC |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208049 | ACCORD HLTHCARE |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 213248 | ALEMBIC |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 212244 | ALKEM LABS LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208002 | AMNEAL PHARMS CO |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 218174 | ANNORA PHARMA |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208045 | AUROBINDO PHARMA LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208058 | AVET LIFESCIENCES |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208047 | DR REDDYS |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208028 | INVAGEN PHARMS |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208031 | LUPIN LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 212124 | MACLEODS PHARMS LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208037 | MSN |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 212091 | SLATE RUN PHARMA |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208066 | SUN PHARM |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208055 | TORRENT |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 208052 | ZYDUS PHARMS |
TABLET;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LATUDA | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | Yes | AB | 200603 | SUNOVION PHARMS INC |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 208049 | ACCORD HLTHCARE |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 213248 | ALEMBIC |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 212244 | ALKEM LABS LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 208002 | AMNEAL PHARMS CO |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 218174 | ANNORA PHARMA |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 208045 | AUROBINDO PHARMA LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 208058 | AVET LIFESCIENCES |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 208047 | DR REDDYS |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 208028 | INVAGEN PHARMS |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 208031 | LUPIN LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 212124 | MACLEODS PHARMS LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 208037 | MSN |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 212091 | SLATE RUN PHARMA |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 208066 | SUN PHARM |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 208055 | TORRENT |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 208052 | ZYDUS PHARMS |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LATUDA | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 200603 | SUNOVION PHARMS INC |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208049 | ACCORD HLTHCARE |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 213248 | ALEMBIC |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 212244 | ALKEM LABS LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208002 | AMNEAL PHARMS CO |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 218174 | ANNORA PHARMA |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208045 | AUROBINDO PHARMA LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208058 | AVET LIFESCIENCES |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208047 | DR REDDYS |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208028 | INVAGEN PHARMS |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208031 | LUPIN LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 212124 | MACLEODS PHARMS LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208037 | MSN |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 212091 | SLATE RUN PHARMA |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208066 | SUN PHARM |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208055 | TORRENT |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208052 | ZYDUS PHARMS |
TABLET;ORAL; 120MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LATUDA | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | Yes | AB | 200603 | SUNOVION PHARMS INC |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 208049 | ACCORD HLTHCARE |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 213248 | ALEMBIC |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 212244 | ALKEM LABS LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 208002 | AMNEAL PHARMS CO |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 218174 | ANNORA PHARMA |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 208045 | AUROBINDO PHARMA LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 208058 | AVET LIFESCIENCES |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 208028 | INVAGEN PHARMS |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 208031 | LUPIN LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 212124 | MACLEODS PHARMS LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 208037 | MSN |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 212091 | SLATE RUN PHARMA |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 208066 | SUN PHARM |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 208055 | TORRENT |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 208052 | ZYDUS PHARMS |
TABLET;ORAL; 60MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LATUDA | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | Yes | AB | 200603 | SUNOVION PHARMS INC |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208049 | ACCORD HLTHCARE |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 213248 | ALEMBIC |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 212244 | ALKEM LABS LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208002 | AMNEAL PHARMS CO |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 218174 | ANNORA PHARMA |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208045 | AUROBINDO PHARMA LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208058 | AVET LIFESCIENCES |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208047 | DR REDDYS |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208028 | INVAGEN PHARMS |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208031 | LUPIN LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 212124 | MACLEODS PHARMS LTD |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208037 | MSN |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 212091 | SLATE RUN PHARMA |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208066 | SUN PHARM |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | No | AB | 208052 | ZYDUS PHARMS |