Amethyst

Amethyst

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

Company

DUNS: 119723554

Effective Date

December 31, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Products1

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

NDC Product Code

52544-295

Application Number

ANDA079218

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 31, 2021

Ingredients

Code: 423D2T571UClass: ACTIBQuantity: 20 ug in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

Code: 5W7SIA7YZWClass: ACTIBQuantity: 90 ug in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT