Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rebel Distributors Corp.
Rebel Distributors Corp.
118802834
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
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Product Details
NDC Product Code
21695-443Application Number
ANDA078666Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 1, 2009LevonorgestrelActive
Code: 5W7SIA7YZWClass: ACTIBQuantity: 0.75 mg in 1 1
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT