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.
PRAVASTATIN SODIUM
Product Details
NDC Product Code
70934-236Application Number
ANDA207068Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 4, 2021LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
PravastatinActive
Code: 3M8608UQ61Class: ACTIBQuantity: 40 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT