Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Gland Pharma Limited
918601238
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Pharma Limited
ApoPharma USA, Inc.
Gland Pharma Limited
918601238
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Deferoxamine mesylate
Product Details
NDC Product Code
52609-4504Application Number
ANDA207384Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
October 7, 2017DeferoxamineActive
Code: V9TKO7EO6KClass: ACTIBQuantity: 2 g in 1 1
Deferoxamine mesylate
Product Details
NDC Product Code
52609-4505Application Number
ANDA207384Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSEffective Date
October 7, 2017DeferoxamineActive
Code: V9TKO7EO6KClass: ACTIBQuantity: 500 mg in 1 1