Aurovela 1.5/30

Manufacturing Establishments1

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

Labeler

Aurobindo Pharma Limited

DUNS Number

650381903

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

NDC Product Code

65862-935

Application Number

ANDA207581

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 21, 2023

Ingredients

Code: 9S44LIC7OJClass: ACTIBQuantity: 1.5 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

.ALPHA.-TOCOPHEROLInactive

Code: H4N855PNZ1Class: IACT

Code: 423D2T571UClass: ACTIBQuantity: 30 ug in 1 1