Details for New Drug Application (NDA): 021323
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NDA 021323 describes LEXAPRO, which is a drug marketed by Abbvie and is included in two NDAs. It is available from one supplier. Additional details are available on the LEXAPRO profile page.
The generic ingredient in LEXAPRO is escitalopram oxalate. There are twenty-six drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
The generic ingredient in LEXAPRO is escitalopram oxalate. There are twenty-six drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
Summary for 021323
| Tradename: | LEXAPRO |
| Applicant: | Abbvie |
| Ingredient: | escitalopram oxalate |
| Patents: | 0 |
Pharmacology for NDA: 021323
| Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 021323
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323 | NDA | Allergan, Inc. | 0456-2005 | 0456-2005-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0456-2005-01) |
| LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323 | NDA | Allergan, Inc. | 0456-2010 | 0456-2010-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0456-2010-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Aug 14, 2002 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | May 12, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Aug 14, 2002 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | May 12, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Aug 14, 2002 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | May 12, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Expired US Patents for NDA 021323
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-003 | Aug 14, 2002 | 6,916,941*PED | ⤷ Get Started Free |
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-001 | Aug 14, 2002 | 6,916,941*PED | ⤷ Get Started Free |
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-003 | Aug 14, 2002 | 7,420,069*PED | ⤷ Get Started Free |
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-003 | Aug 14, 2002 | RE34712*PED | ⤷ Get Started Free |
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-002 | Aug 14, 2002 | RE34712*PED | ⤷ Get Started Free |
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-002 | Aug 14, 2002 | 6,916,941*PED | ⤷ Get Started Free |
| Abbvie | LEXAPRO | escitalopram oxalate | TABLET;ORAL | 021323-002 | Aug 14, 2002 | 7,420,069*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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