Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PD-Rx Pharmaceuticals, Inc.
156893695
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
156893695
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cyclobenzaprine Hydrochloride
Product Details
NDC Product Code
43063-516Application Number
ANDA078048Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 26, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
CyclobenzaprineActive
Code: 0VE05JYS2PClass: ACTIBQuantity: 10 mg in 1 1