Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208644
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, 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 |
---|---|---|---|---|---|---|---|
04/24/2018 | 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 |
---|---|---|---|---|---|
10/31/2023 | SUPPL-17 | Labeling, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
06/02/2023 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/14/2022 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/14/2021 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/19/2018 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
RABEPRAZOLE SODIUM
TABLET, DELAYED RELEASE;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACIPHEX | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 020973 | WOODWARD |
RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 208644 | ALKEM LABS LTD |
RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 204179 | AMNEAL PHARMS |
RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 205761 | AUROBINDO PHARMA |
RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078964 | CHARTWELL RX |
RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 076824 | DR REDDYS |
RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090678 | LANNETT CO INC |
RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 204237 | RUBICON |
RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202376 | TORRENT |