Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Chartwell Pharmaceuticals Congers, LLC
Chartwell RX, LLC
Chartwell Pharmaceuticals Congers, LLC
118673447
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TERBINAFINE
Product Details
NDC Product Code
62135-572Application Number
ANDA078199Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 6, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHYLCELLULOSE, UNSPECIFIEDInactive
Code: Z944H5SN0HClass: IACT
TerbinafineActive
Code: 012C11ZU6GClass: ACTIMQuantity: 250 mg in 1 1