Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Douglas Manufacturing Limited
Upsher-Smith Laboratories, Inc.
590829388
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
0832-0595Application Number
ANDA209208Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 31, 2022ExemestaneActive
Code: NY22HMQ4BXClass: ACTIBQuantity: 25 mg in 1 1
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WOClass: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2Class: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1AClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
crospovidone (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT