FDA.reportPublic FDA data

Application 091281

Type
ANDA
Sponsor
TWI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL15MGNoNo
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24979-035Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-035Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-036Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
24979-036Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideTWi Pharmaceuticals, Inc.ANDACurrent
55700-857Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideQuality Care Products, LLCANDACurrent
55700-858Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideQuality Care Products, LLCANDACurrent
71205-454Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71205-454Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71205-857Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71205-858Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
72189-101CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXANDACurrent