FDA.reportPublic FDA data

Application 078722

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL7.5MGNoNo
003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-859CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAidarex Pharmaceuticals LLCANDACurrent
42254-239CYCLOBENZAPRINE HYROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDERebel Distributors CorpANDACurrent
45865-685Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideMedsource PharmaceuticalsANDACurrent
50090-1848Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1848Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50436-1101Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideUnit Dose ServicesANDACurrent
53149-4841Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAll Pharma, LLCANDACurrent
53149-4852Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAll Pharma, LLCANDACurrent
53217-170Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
55700-239Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-239Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-239Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-239Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-762Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideQuality Care Products, LLCANDACurrent
55700-762Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideQuality Care Products, LLCANDACurrent
61919-025CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-261CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-261CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-261CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-261CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-261CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_RxANDACurrent
61919-414CYCLOBENZPRINE HCLCYCLOBENZPRINE HCLDIRECTRXANDACurrent
61919-414CYCLOBENZPRINE HCLCYCLOBENZPRINE HCLDIRECTRXANDACurrent
61919-681CYCLOBENZAPRINE HCICYCLOBENZAPRINE HCIDIRECTRXANDACurrent
61919-681CYCLOBENZAPRINE HCICYCLOBENZAPRINE HCIDIRECTRXANDACurrent
61919-681CYCLOBENZAPRINE HCICYCLOBENZAPRINE HCIDIRECTRXANDACurrent
61919-681CYCLOBENZAPRINE HCICYCLOBENZAPRINE HCIDIRECTRXANDACurrent
61919-681CYCLOBENZAPRINE HCICYCLOBENZAPRINE HCIDIRECTRXANDACurrent
61919-681CYCLOBENZAPRINE HCICYCLOBENZAPRINE HCIDIRECTRXANDACurrent
63187-123CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPANDACurrent
63187-590Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-590Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-590Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-923Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-923Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63304-214Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRanbaxy Pharmaceuticals IncANDACurrent
63304-215Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRanbaxy Pharmaceuticals IncANDACurrent
63304-216Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRanbaxy Pharmaceuticals IncANDACurrent
63629-4664CYCLOBENZAPRINE HYROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
68071-1961Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1961Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1961Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68258-7150CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDispensing Solutions, Inc.ANDACurrent
68788-9967Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9967Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9967Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9967Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9967Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
69306-075Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideDoc RxANDACurrent
69306-075Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideDoc RxANDACurrent
69306-075Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideDoc RxANDACurrent
69420-1001Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSA3, LLCANDACurrent
69420-1001Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSA3, LLCANDACurrent
69420-1001Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSA3, LLCANDACurrent
69420-1001Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSA3, LLCANDACurrent
69420-1001Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSA3, LLCANDACurrent
71085-010Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideIPG PHARMACEUTICALS, INC.ANDACurrent
71205-132Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71205-132Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71205-132Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71335-0096Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0096Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0096Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0096Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
71800-003Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideInnovida Pharmaceutique CorporationANDACurrent
71800-003Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideInnovida Pharmaceutique CorporationANDACurrent
71800-003Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideInnovida Pharmaceutique CorporationANDACurrent
73086-1001NOpiod-TCCyclobenzaprine Hydrochloride, Lidocaine, MentholSkya Health, LLCANDACurrent
73086-1001NOpiod-TCCyclobenzaprine Hydrochloride, Lidocaine, MentholSkya Health, LLCANDACurrent
73086-901NOpioid-TCCyclobenzaprine Hydrochloride, Lidocaine, MentholSkya Health, LLCANDACurrent
73086-905NOpioid-LMCCyclobenzaprine Hydrochloride, Lidocaine, MentholSkya Health, LLCANDACurrent
73086-906NOpioid-LMCCyclobenzaprine Hydrochloride, Lidocaine and MentholSkya Health, LLCANDACurrent
76420-010Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAsclemed USA, Inc.ANDACurrent
76420-010Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAsclemed USA, Inc.ANDACurrent
76420-010Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAsclemed USA, Inc.ANDACurrent
76420-019Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAsclemed USA, Inc.ANDACurrent
76519-1000CYCLOBENZAPRINE HYROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEH.J. Harkins Company, Inc.ANDACurrent
80425-0015FlexerilCyclobenzaprine HydrochlorideADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent
80425-0015Cyclobenzaprine HCLCyclobenzaprine HCLADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent
80425-0015Cyclobenzaprine HCLCyclobenzaprine HCLADVANCED RX PHARMACY OF TENNESSEE, LLCANDACurrent