Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208049
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | AB | No | No |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET;ORAL | Prescription | AB | No | No |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | AB | No | No |
| LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | AB | No | 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 |
|---|---|---|---|---|---|---|---|
| 01/03/2019 | ORIG-1 | Approval | 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 |
|---|---|---|---|---|---|
| 01/13/2022 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
LURASIDONE HYDROCHLORIDE
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; 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; 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 |
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; 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 |