Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Direct_Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct_Rx
Direct_Rx
Direct_Rx
079254320
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Junel FE
Product Details
NDC Product Code
72189-215Application Number
ANDA076380Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 6, 2022SUCROSEInactive
Code: C151H8M554Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
EthinylestradiolActive
Code: 423D2T571UClass: ACTIBQuantity: 20 ug in 1 1
ACACIAInactive
Code: 5C5403N26OClass: IACT
NorethisteroneActive
Code: 9S44LIC7OJClass: ACTIBQuantity: 1 mg in 1 1
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT