Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Orient Pharma Co., Ltd.
658849810
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Orient Pharma Co., Ltd.
Teva Pharmaceuticals, Inc.
Orient Pharma Co., Ltd.
658849810
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pitavastatin
Product Details
NDC Product Code
0480-3633Application Number
ANDA205932Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 10, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PitavastatinActive
Code: IYD54XEG3WClass: ACTIMQuantity: 4.18 mg in 1 1
Pitavastatin
Product Details
NDC Product Code
0480-3631Application Number
ANDA205932Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 10, 2023TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
PitavastatinActive
Code: IYD54XEG3WClass: ACTIMQuantity: 1.045 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
Pitavastatin
Product Details
NDC Product Code
0480-3632Application Number
ANDA205932Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 10, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
PitavastatinActive
Code: IYD54XEG3WClass: ACTIMQuantity: 2.09 mg in 1 1