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FDA Approval

Amethyst

CompanyTeva Pharmaceuticals, Inc. (DUNS: 022629579)

Effective Date

January 31, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Levonorgestrel(90 ug in 1 1)

Ethinylestradiol(20 ug in 1 1)

Products (1)

Amethyst

NDC Product Code

0480-3472

Application Number

ANDA079218

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 6, 2023

Ingredients

LevonorgestrelActive

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

EthinylestradiolActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

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