Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 208031
Company: LUPIN LTD
Company: LUPIN LTD
| 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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208031Orig1s000TALtr.pdf |
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 | 208002 | AMNEAL PHARMS CO |
| 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 | 208066 | SUN PHARMA GLOBAL |
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 | 208002 | AMNEAL PHARMS CO |
| 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 | 208066 | SUN PHARMA GLOBAL |
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 | 208002 | AMNEAL PHARMS CO |
| 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 | 208066 | SUN PHARMA GLOBAL |
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 | 208002 | AMNEAL PHARMS CO |
| 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 | 208066 | SUN PHARMA GLOBAL |
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 | 208002 | AMNEAL PHARMS CO |
| 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 | 208066 | SUN PHARMA GLOBAL |
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