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FDA Approval

Anagrelide Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
August 4, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Anagrelide(0.5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Carilion Materials Management

Carilion Materials Management

079239644

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Anagrelide Hydrochloride

Product Details

NDC Product Code
68151-2959
Application Number
ANDA076468
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 8, 2015
Code: VNS4435G39Class: ACTIMQuantity: 0.5 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7LClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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