Drugs@FDA: FDA-Approved Drugs
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
04/02/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/18/2023 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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11/23/2022 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/20/2021 | SUPPL-16 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/07/2021 | SUPPL-15 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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09/07/2021 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/07/2021 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/07/2021 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/05/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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09/15/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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05/31/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ESCITALOPRAM OXALATE
SOLUTION;ORAL; EQ 5MG BASE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 202227 | AMNEAL PHARMS |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 079062 | AUROBINDO PHARMA LTD |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 090477 | CHARTWELL MOLECULAR |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 202221 | HETERO LABS LTD III |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 202754 | MACLEODS PHARMS LTD |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 079121 | TARO |