ESCITALOPRAM OXALATE | N021323 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2026-P-4103 Lachman Consulting Services, Inc. filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Escitalopram Oxalate Tablets, 15 mg suitable for submission as an ANDA, with Lexapro (Escitalopram) Tablets 5 mg, 10 mg, and 2 | Suitability | 2026-04-15 | Open | Lachman Consulting Services |
Suitability Petition from Newcastle Bioscience, LLC FDA-2024-P-1870 Newcastle Bioscience, LLC filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA declare Escitalopram Oxalate Orally Disintegrating Tablets in 5 mg, 10 mg, 15 mg, and 20 mg strengths suitable for submission as an ANDA, with the reference-listed drug being Lexapro Tablets 20 m | Suitability | 2024-04-16 | Open | Newcastle Bioscience |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| NPP | May 12, 2026 | Expired |