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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
ReadyMeds
DUNS: 072115132
Effective Date
May 5, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Escitalopram(10 mg in 1 1)

Manufacturing Establishments1

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

ReadyMeds

ReadyMeds

072115132

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
64205-585
Application Number
ANDA076765
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 5, 2014
Code: 5U85DBW7LOClass: ACTIMQuantity: 10 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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