Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
H.J. Harkins Company, Inc.
147681894
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
H.J. Harkins Company, Inc.
H.J. Harkins Company, Inc.
H.J. Harkins Company, Inc.
147681894
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
52959-450Application Number
ANDA078665Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 29, 2012LevonorgestrelActive
Code: 5W7SIA7YZWClass: ACTIBQuantity: 0.75 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT