Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PD-Rx Pharmaceuticals, Inc.
156893695
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
156893695
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Atenolol and Chlorthalidone
Product Details
NDC Product Code
55289-993Application Number
ANDA073665Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 22, 2023CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
AtenololActive
Code: 50VV3VW0TIClass: ACTIBQuantity: 50 mg in 1 1
ChlorthalidoneActive
Code: Q0MQD1073QClass: ACTIBQuantity: 25 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT