Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207394
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | No | No |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;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 |
---|---|---|---|---|---|---|---|
01/18/2019 | 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 |
---|---|---|---|---|---|
02/23/2024 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
02/23/2024 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
02/23/2024 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
LANSOPRAZOLE
CAPSULE, DELAYED REL PELLETS;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 207394 | ALKEM LABS LTD |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 207156 | CHARTWELL MOLECULAR |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 091269 | DR REDDYS LABS LTD |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203083 | HETERO LABS LTD III |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 205868 | INVENTIA |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090763 | MYLAN PHARMS INC |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 201921 | NATCO PHARMA LTD |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090331 | SANDOZ |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202637 | SUN PHARM |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 077255 | TEVA PHARMS |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202176 | WOCKHARDT |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203203 | XIROMED |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202366 | ZYDUS HLTHCARE |
CAPSULE, DELAYED REL PELLETS;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 207394 | ALKEM LABS LTD |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 207156 | CHARTWELL MOLECULAR |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 091269 | DR REDDYS LABS LTD |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203083 | HETERO LABS LTD III |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 205868 | INVENTIA |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090763 | MYLAN PHARMS INC |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 201921 | NATCO PHARMA LTD |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090331 | SANDOZ |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 091509 | SUN PHARM |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 077255 | TEVA PHARMS |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202176 | WOCKHARDT |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203203 | XIROMED |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202366 | ZYDUS HLTHCARE |
PREVACID | LANSOPRAZOLE | 30MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 020406 | TAKEDA PHARMS USA |