Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Northwind Pharmaceuticals, LLC
036986393
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Northwind Pharmaceuticals, LLC
Northwind Pharmaceuticals, LLC
Northwind Pharmaceuticals, LLC
036986393
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loratadine
Product Details
NDC Product Code
51655-027Application Number
ANDA076134Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 31, 2014LoratadineActive
Code: 7AJO3BO7QNClass: ACTIBQuantity: 10 mg in 1 1