Details for New Drug Application (NDA): 078777
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NDA 078777 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 078777
| Tradename: | ESCITALOPRAM OXALATE |
| Applicant: | Graviti Pharms |
| Ingredient: | escitalopram oxalate |
| Patents: | 0 |
Pharmacology for NDA: 078777
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 078777
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESCITALOPRAM OXALATE | escitalopram oxalate | TABLET;ORAL | 078777 | ANDA | Rising Pharma Holdings, Inc. | 16571-755 | 16571-755-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16571-755-01) |
| ESCITALOPRAM OXALATE | escitalopram oxalate | TABLET;ORAL | 078777 | ANDA | Rising Pharma Holdings, Inc. | 16571-755 | 16571-755-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (16571-755-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Sep 11, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Sep 11, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Sep 11, 2012 | TE: | AB | RLD: | No | ||||
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