MedPath
FDA Product

Dolishale

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Dolishale

50742-659

Regulatory Information

50742-659

ANDA091692

C73584

December 11, 2020

USA

DOLISHALE (90 mcg levonorgestrel and 20 mcg ethinyl estradiol) Tablets, USP

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

833250017

Active Ingredients

LEVONORGESTREL

Quantity: 90 ug in 1 1

Code: 5W7SIA7YZW

Class Code: ACTIB

ETHINYL ESTRADIOL

Quantity: 20 ug in 1 1

Code: 423D2T571U

Class Code: ACTIB

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

POLYETHYLENE GLYCOL 3000

Code: SA1B764746

Class Code: IACT

FD&C BLUE NO. 2--ALUMINUM LAKE

Code: 4AQJ3LG584

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

LECITHIN, SOYBEAN

Code: 1DI56QDM62

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FD&C YELLOW NO. 5

Code: I753WB2F1M

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

ETHINYL ESTRADIOL

Code: 423D2T571U

LEVONORGESTREL

Code: 5W7SIA7YZW

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