Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Torrent Pharma, Inc.
790033935
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Torrent Pharmaceuticals Limited
Torrent Pharmaceuticals Limited
Torrent Pharma, Inc.
916488547
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
anagrelide
Product Details
NDC Product Code
13668-453Application Number
ANDA209151Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 21, 2022CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
AnagrelideActive
Code: VNS4435G39Class: ACTIMQuantity: 0.5 mg in 1 1
anagrelide
Product Details
NDC Product Code
13668-462Application Number
ANDA209151Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 21, 2022CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
AnagrelideActive
Code: VNS4435G39Class: ACTIMQuantity: 1 mg in 1 1