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
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