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.
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Denton Pharma, Inc. dba Northwind Pharmaceuticals
080355546
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bisoprolol fumarate and hydrochlorothiazide
Product Details
NDC Product Code
70934-705Application Number
ANDA079106Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 12, 2021STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
BisoprololActive
Code: UR59KN573LClass: ACTIBQuantity: 5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
COPOVIDONEInactive
Code: D9C330MD8BClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WEClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 6.25 mg in 1 1