Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
189630168
Products2
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
23155-287Application Number
ANDA205530Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 1, 2022AcetazolamideActive
Code: O3FX965V0IClass: ACTIBQuantity: 125 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
acetazolamide
Product Details
NDC Product Code
23155-288Application Number
ANDA205530Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 1, 2022AcetazolamideActive
Code: O3FX965V0IClass: ACTIBQuantity: 250 mg in 1 1
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT