Application 076003

Type
ANDA
Sponsor
AMNEAL PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8005Tramadol HydrochlorideTramadol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8005Tramadol HydrochlorideTramadol HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8005Tramadol HydrochlorideTramadol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-009Tramadol HydrochlorideTramadol HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10544-531Tramadol HydrochlorideTramadol HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
12634-786TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEAPOTHECA, INCANDACurrent
21695-132Tramadol HydrochlorideTramadol HydrochlorideRebel Distributors Corp.ANDACurrent
24236-609Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
33261-105Tramadol HydrochlorideTramadol HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33358-342Tramadol HydrochlorideTramadol HydrochlorideRxChange Co.ANDACurrent
35356-659Tramadol HydrochlorideTramadol HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
43353-072Tramadol HydrochlorideTramadol HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2099Tramadol HydrochlorideTramadol HydrochlorideA-S Medication SolutionsANDACurrent
50090-2100Tramadol HydrochlorideTramadol HydrochlorideA-S Medication SolutionsANDACurrent
50090-3000Tramadol HydrochlorideTramadol HydrochlorideA-S Medication SolutionsANDACurrent
50436-8787Tramadol HydrochlorideTramadol HydrochlorideUnit Dose ServicesANDACurrent
50436-8787Tramadol HydrochlorideTramadol HydrochlorideUnit Dose ServicesANDACurrent
51138-077Tramadol HydrochlorideTramadol HydrochlorideMed-Health Pharma, LLCANDACurrent
51655-185UltramTRAMADOL HCLNORTHWIND PHARMACEUTICALSANDACurrent
53002-4320Tramadol HydrochlorideTramadol HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-4320Tramadol HydrochlorideTramadol HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
60760-622Tramadol HydrochlorideTramadol HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-073TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
61919-073TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
61919-073TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
61919-073TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
61919-073TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
61919-073TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirect_RxANDACurrent
61919-073TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
61919-073TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
63187-063Tramadol HydrochlorideTramadol HydrochlorideProficient Rx LPANDACurrent
63187-063Tramadol HydrochlorideTramadol HydrochlorideProficient Rx LPANDACurrent
63629-4899Tramadol HydrochlorideTramadol HydrochlorideBryant Ranch PrepackANDACurrent
63629-4899Tramadol HydrochlorideTramadol HydrochlorideBryant Ranch PrepackANDACurrent
63629-4899Tramadol HydrochlorideTramadol HydrochlorideBryant Ranch PrepackANDACurrent
63739-671Tramadol HydrochlorideTramadol HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63874-532Tramadol HydrochlorideTramadol HydrochlorideAltura Pharmaceuticals, Inc.ANDACurrent
64205-627Tramadol HydrochlorideTramadol HydrochlorideReadyMedsANDACurrent
65162-627Tramadol HydrochlorideTramadol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-627Tramadol HydrochlorideTramadol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-627Tramadol HydrochlorideTramadol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-627Tramadol HydrochlorideTramadol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-627Tramadol HydrochlorideTramadol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-627Tramadol HydrochlorideTramadol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-627Tramadol HydrochlorideTramadol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-627Tramadol HydrochlorideTramadol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-627Tramadol HydrochlorideTramadol HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
66267-563Tramadol HydrochlorideTramadol HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-563Tramadol HydrochlorideTramadol HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-843Tramadol HydrochlorideTramadol HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-843Tramadol HydrochlorideTramadol HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
67046-730Tramadol HydrochlorideTramadol HydrochlorideContract Pharmacy Services-PAANDACurrent
67296-0389Tramadol HydrochlorideTramadol HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-4119Tramadol HydrochlorideTramadol HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4119Tramadol HydrochlorideTramadol HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4119Tramadol HydrochlorideTramadol HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68084-808Tramadol HydrochlorideTramadol HydrochlorideAmerican Health PackagingANDACurrent
68084-808Tramadol HydrochlorideTramadol HydrochlorideAmerican Health PackagingANDACurrent
68084-808Tramadol HydrochlorideTramadol HydrochlorideAmerican Health PackagingANDACurrent
68084-808Tramadol HydrochlorideTramadol HydrochlorideAmerican Health PackagingANDACurrent
68094-017Tramadol HydrochlorideTramadol HydrochloridePrecision Dose, Inc.ANDACurrent
68094-017Tramadol HydrochlorideTramadol HydrochloridePrecision Dose, Inc.ANDACurrent
68387-900Tramadol HydrochlorideTramadol HydrochlorideKeltman Pharmaceuticals Inc.ANDACurrent
68788-9199Tramadol HydrochlorideTramadol HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
69238-2348Tramadol HydrochlorideTramadol HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
70518-0054Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0118Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0118Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0118Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0118Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0118Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0118Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0118Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0118Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0118Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0118Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0118Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
71610-392Tramadol HydrochlorideTramadol HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
75921-627Tramadol HydrochlorideTramadol HydrochlorideLife Line Home Care Services, Inc.ANDACurrent
80425-0057UltramTramadol HCl 50mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
763050ORIG 12023-11-03
184370ORIG12002-06-20
88470ORIG12002-06-20