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.
Emcure Pharmaceuticals Limited
Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
AVET LIFESCIENCES PRIVATE LIMITED
675467924
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetazolamide
Product Details
NDC Product Code
23155-313Application Number
ANDA202693Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
August 1, 2022SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
AcetazolamideActive
Code: 429ZT169UHClass: ACTIMQuantity: 500 mg in 5 mL