Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Alembic Pharmaceuticals Limited
871411532
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited
871411532
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Docosanol
Product Details
NDC Product Code
46708-682Application Number
ANDA215839Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
May 8, 2025DocosanolActive
Code: 9G1OE216XYClass: ACTIBQuantity: 100 mg in 1 g
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SUCROSE DISTEARATEInactive
Code: 33X4X4B90SClass: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50MClass: IACT