Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Novel Laboratories, Inc.
793518643
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novel Laboratories, Inc.
Pharmacist Pharmaceutical, LLC
Novel Laboratories, Inc.
793518643
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levonorgestrel
Product Details
NDC Product Code
63704-009Application Number
ANDA202508Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 29, 2013LevonorgestrelActive
Code: 5W7SIA7YZWClass: ACTIBQuantity: 1.5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT