Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
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
63629-9162Application Number
ANDA209869Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 26, 2021CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
PravastatinActive
Code: 3M8608UQ61Class: ACTIBQuantity: 10 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT