Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
080355546
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Escitalopram
Product Details
NDC Product Code
70934-957Application Number
ANDA202389Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 5, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JCClass: IACT
EscitalopramActive
Code: 5U85DBW7LOClass: ACTIMQuantity: 5 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT