Details for New Drug Application (NDA): 078032
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NDA 078032 describes ESCITALOPRAM OXALATE, which is a drug marketed by Norvium Bioscience, Amneal Pharms, Antrim Pharms Llc, Aurobindo Pharma Ltd, Chartwell Molecular, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Taro, Accord Hlthcare, Anima, Chartwell Rx, Dash Pharms, Graviti Pharms, Hikma Pharms, Invagen Pharms, Jubilant Cadista, Prinston Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Lifesciences, and is included in twenty-three NDAs. It is available from fifty suppliers. Additional details are available on the ESCITALOPRAM OXALATE profile page.
The generic ingredient in ESCITALOPRAM OXALATE is escitalopram oxalate. There are twenty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
The generic ingredient in ESCITALOPRAM OXALATE is escitalopram oxalate. There are twenty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
Summary for 078032
| Tradename: | ESCITALOPRAM OXALATE |
| Applicant: | Prinston Inc |
| Ingredient: | escitalopram oxalate |
| Patents: | 0 |
Pharmacology for NDA: 078032
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 078032
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESCITALOPRAM OXALATE | escitalopram oxalate | TABLET;ORAL | 078032 | ANDA | QPharma Inc | 42708-155 | 42708-155-30 | 30 TABLET, FILM COATED in 1 BOTTLE (42708-155-30) |
| ESCITALOPRAM OXALATE | escitalopram oxalate | TABLET;ORAL | 078032 | ANDA | QPharma Inc | 42708-163 | 42708-163-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-163-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Aug 28, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Aug 28, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Aug 28, 2015 | TE: | AB | RLD: | No | ||||
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