Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202666
Company: TWI PHARMS
Company: TWI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE;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 |
---|---|---|---|---|---|---|---|
09/16/2022 | ORIG-1 | Approval |
Label is not available on this site. |
DEXLANSOPRAZOLE
CAPSULE, DELAYED RELEASE;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXILANT | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 022287 | TAKEDA PHARMS USA |
DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 205205 | MYLAN |
DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 202294 | PAR PHARM INC |
DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 202666 | TWI PHARMS |
CAPSULE, DELAYED RELEASE;ORAL; 60MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXILANT | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 022287 | TAKEDA PHARMS USA |
DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 205205 | MYLAN |
DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 202294 | PAR PHARM INC |
DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 202666 | TWI PHARMS |