Drugs@FDA: FDA-Approved Drugs
Company: MYLAN PHARMS INC
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 |
---|---|---|---|---|---|---|---|
11/10/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090763s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/14/2024 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
02/14/2024 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/14/2024 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/14/2024 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
03/16/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
08/27/2013 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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08/28/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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08/28/2012 | SUPPL-2 | Labeling-Package Insert |
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 |