Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
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
71335-0658Application Number
ANDA090432Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 7, 2021EscitalopramActive
Code: 5U85DBW7LOClass: ACTIMQuantity: 20 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT