Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
AVET LIFESCIENCES PRIVATE LIMITED
853181664
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Maiva Pharma Private Limited
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
AVET LIFESCIENCES PRIVATE LIMITED
725656438
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CIDOFOVIR DIHYDRATE
Product Details
NDC Product Code
23155-216Application Number
ANDA202501Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
April 21, 2021CidofovirActive
Code: JIL713Q00NClass: ACTIMQuantity: 375 mg in 5 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT