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FDA Approval

Escitalopram

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 20, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Escitalopram(20 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

medsource pharmaceuticals

medsource pharmaceuticals

833685915

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
45865-699
Application Number
ANDA202389
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 20, 2018
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JCClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
Code: 5U85DBW7LOClass: ACTIMQuantity: 20 mg in 1 1
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