Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
GAVIS Pharmaceuticals, LLC.
829838551
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novel Laboratories, Inc.
GAVIS Pharmaceuticals, LLC.
GAVIS Pharmaceuticals, LLC.
793518643
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
My Way
Product Details
NDC Product Code
43386-620Application Number
ANDA202508Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 27, 2013SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LevonorgestrelActive
Code: 5W7SIA7YZWClass: ACTIBQuantity: 1.5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT