Details for New Drug Application (NDA): 078604
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NDA 078604 describes ESCITALOPRAM OXALATE, which is a drug marketed by Rising, Amneal Pharms, Antrim Pharms Llc, Aurobindo Pharma Ltd, Chartwell Molecular, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Sun Pharma Canada, Accord Hlthcare, Aiping Pharm Inc, Ascent Pharms Inc, Chartwell Rx, Graviti Pharms, Hikma Pharms, Invagen Pharms, Jubilant Cadista, Micro Labs, Novitium Pharma, Prinston Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Lifesciences, and is included in twenty-five NDAs. It is available from forty-two suppliers. Additional details are available on the ESCITALOPRAM OXALATE profile page.
The generic ingredient in ESCITALOPRAM OXALATE is escitalopram oxalate. There is one drug master file entry for this compound. Forty-four 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 is one drug master file entry for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
Summary for 078604
| Tradename: | ESCITALOPRAM OXALATE |
| Applicant: | Invagen Pharms |
| Ingredient: | escitalopram oxalate |
| Patents: | 0 |
Pharmacology for NDA: 078604
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 078604
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESCITALOPRAM OXALATE | escitalopram oxalate | TABLET;ORAL | 078604 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 53401-037 | 53401-037-53 | 60 TABLET, FILM COATED in 1 BOTTLE (53401-037-53) |
| ESCITALOPRAM OXALATE | escitalopram oxalate | TABLET;ORAL | 078604 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 53401-037 | 53401-037-60 | 90 TABLET, FILM COATED in 1 BOTTLE (53401-037-60) |
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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