Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200816
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, 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 |
---|---|---|---|---|---|---|---|
11/27/2018 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/14/2021 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/14/2021 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
LANSOPRAZOLE
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 207167 | AUROBINDO PHARMA LTD |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 210465 | DR REDDYS |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 202396 | MYLAN |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 208784 | TEVA PHARMS USA |
LANSOPRAZOLE | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 200816 | ZYDUS PHARMS |
PREVACID | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 021428 | TAKEDA PHARMS USA |
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL; 30MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 207167 | AUROBINDO PHARMA LTD |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 210465 | DR REDDYS |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 202396 | MYLAN |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 208784 | TEVA PHARMS USA |
LANSOPRAZOLE | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | No | AB | 200816 | ZYDUS PHARMS |
PREVACID | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 021428 | TAKEDA PHARMS USA |