Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078032
Company: PRINSTON INC
Company: PRINSTON INC
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 |
---|---|---|---|---|---|---|---|
08/28/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078032s000TAltr.pdf |
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 |