Details for New Drug Application (NDA): 021365
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NDA 021365 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. Fifty-one 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. Fifty-one suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
Summary for 021365
| Tradename: | LEXAPRO |
| Applicant: | Abbvie |
| Ingredient: | escitalopram oxalate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 27, 2002 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 12, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Expired US Patents for NDA 021365
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | LEXAPRO | escitalopram oxalate | SOLUTION;ORAL | 021365-001 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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