Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205379
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
09/25/2015 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205379Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205379Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/17/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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04/17/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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04/17/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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04/17/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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04/17/2020 | SUPPL-2 | Labeling-Container/Carton Labels, 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 |
---|---|---|---|---|---|
09/25/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205379Orig1s000lbl.pdf |
ESOMEPRAZOLE SODIUM
INJECTABLE;INTRAVENOUS; EQ 40MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205379 | ACCORD HLTHCARE |
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207181 | DEVA HOLDING AS |
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204657 | EUGIA PHARMA |
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203349 | GLAND PHARMA LTD |
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215732 | HAINAN POLY |
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 200882 | SUN PHARM |
NEXIUM IV | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 021689 | ASTRAZENECA |