Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
LUPIN LIMITED
675923163
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
LUPIN LIMITED
LUPIN LIMITED
LUPIN LIMITED
863645527
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lisinopril and Hydrochlorothiazide
Product Details
NDC Product Code
57297-520Application Number
ANDA077912Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 9, 2016MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 20 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT