Dolishale
DOLISHALE (90 mcg levonorgestrel and 20 mcg ethinyl estradiol) Tablets, USP
Approved
Approval ID
036a15be-8c2e-4f65-b5dc-f333e2994d4a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2021
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levonorgestrel and Ethinyl Estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-659
Application NumberANDA091692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levonorgestrel and Ethinyl Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2020
FDA Product Classification
INGREDIENTS (13)
LEVONORGESTRELActive
Quantity: 90 ug in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB
ETHINYL ESTRADIOLActive
Quantity: 20 ug in 1 1
Code: 423D2T571U
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT