Drugs@FDA: FDA-Approved Drugs
Company: MACLEODS PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;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 |
---|---|---|---|---|---|---|---|
09/11/2012 | 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 |
---|---|---|---|---|---|
06/07/2023 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/10/2021 | SUPPL-27 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
12/10/2021 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/10/2021 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/10/2021 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
09/09/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
12/13/2014 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/21/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
05/21/2013 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
ESCITALOPRAM OXALATE
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 202389 | ACCORD HLTHCARE |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 205619 | AMNEAL PHARMS |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 090432 | AUROBINDO PHARMA LTD |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078169 | CHARTWELL RX |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078777 | GRAVITI PHARMS |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078604 | INVAGEN PHARMS |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 202280 | JUBILANT CADISTA |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 202210 | MACLEODS PHARMS LTD |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078032 | PRINSTON INC |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 090939 | TORRENT PHARMS LTD |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 077734 | ZYDUS LIFESCIENCES |
LEXAPRO | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021323 | ABBVIE |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202389 | ACCORD HLTHCARE |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205619 | AMNEAL PHARMS |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 090432 | AUROBINDO PHARMA LTD |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078169 | CHARTWELL RX |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078777 | GRAVITI PHARMS |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078604 | INVAGEN PHARMS |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202280 | JUBILANT CADISTA |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202210 | MACLEODS PHARMS LTD |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078032 | PRINSTON INC |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 090939 | TORRENT PHARMS LTD |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077734 | ZYDUS LIFESCIENCES |
LEXAPRO | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021323 | ABBVIE |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 202389 | ACCORD HLTHCARE |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205619 | AMNEAL PHARMS |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 090432 | AUROBINDO PHARMA LTD |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078169 | CHARTWELL RX |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078777 | GRAVITI PHARMS |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078604 | INVAGEN PHARMS |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 202280 | JUBILANT CADISTA |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 202210 | MACLEODS PHARMS LTD |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078032 | PRINSTON INC |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 090939 | TORRENT PHARMS LTD |
ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077734 | ZYDUS LIFESCIENCES |
LEXAPRO | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021323 | ABBVIE |