Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Direct_Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct_Rx
Direct_Rx
Direct_Rx
079254320
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
61919-734Application Number
ANDA207068Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 15, 2019MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
PravastatinActive
Code: 3M8608UQ61Class: ACTIBQuantity: 80 mg in 1 1