Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078964
Company: CHARTWELL RX
Company: CHARTWELL RX
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 |
---|---|---|---|---|---|---|---|
11/08/2013 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/078964Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/078964Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/31/2023 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/08/2023 | SUPPL-20 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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05/08/2023 | SUPPL-18 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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02/01/2019 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/01/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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02/01/2019 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/01/2019 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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04/03/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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04/03/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/08/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/078964Orig1s000lbl.pdf |
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 | WAYLIS THERAP |
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 |