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.
Triamterene and Hydrochlorothiazide
Product Details
NDC Product Code
70934-143Application Number
ANDA071251Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 22, 2019FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TriamtereneActive
Code: WS821Z52LQClass: ACTIBQuantity: 37.5 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1