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FDA Approval

Exemestane

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

FDA Approval Summary

Company
Eirgen Pharma Ltd
DUNS: 989968644
Effective Date
February 9, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Exemestane(25 mg in 1 1)

Manufacturing Establishments1

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

Eirgen Pharma Ltd

Eirgen Pharma Ltd

989968644

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Exemestane

Product Details

NDC Product Code
44278-025
Application Number
ANDA200898
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 9, 2021
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Code: NY22HMQ4BXClass: ACTIBQuantity: 25 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
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