FDA.report

Application 077903

Type
ANDA
Sponsor
TORRENT PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;ORAL5MGNoNo
002ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;ORAL10MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6082ZOLPIDEM TARTRATEzolpidem tartrateMajor PharmaceuticalsANDACurrent
0904-6082ZOLPIDEM TARTRATEzolpidem tartrateMajor PharmaceuticalsANDACurrent
0904-6082ZOLPIDEM TARTRATEzolpidem tartrateMajor PharmaceuticalsANDACurrent
0904-6083ZOLPIDEM TARTRATEzolpidem tartrateMajor PharmaceuticalsANDACurrent
0904-6083ZOLPIDEM TARTRATEzolpidem tartrateMajor PharmaceuticalsANDACurrent
13668-007ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-007ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-007ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-007ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-007ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-007ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-007ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-008ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-008ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-008ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-008ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-008ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-008ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
13668-008ZOLPIDEM TARTRATEzolpidem tartrateTorrent Pharmaceuticals LimitedANDACurrent
21695-506ZOLPIDEM TARTRATEzolpidem tartrateRebel Distributors Corp.ANDACurrent
21695-507ZOLPIDEM TARTRATEzolpidem tartrateRebel Distributors Corp.ANDACurrent
33261-172ZOLPIDEM TARTRATEzolpidem tartrateAidarex Pharmaceuticals LLCANDACurrent
33261-173ZOLPIDEM TARTRATEzolpidem tartrateAidarex Pharmaceuticals LLCANDACurrent
33358-420ZOLPIDEM TARTRATEzolpidem tartrateRxChange Co.ANDACurrent
33358-439ZOLPIDEM TARTRATEzolpidem tartrateRxChange Co.ANDACurrent
43063-639ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-639ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-639ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-639ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-639ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-639ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-639ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-639ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-639ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-639ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-652ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-652ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-652ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-652ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-652ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-652ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-652ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-652ZOLPIDEM TARTRATEzolpidem tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-242ZOLPIDEM TARTRATEzolpidem tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-242ZOLPIDEM TARTRATEzolpidem tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-243ZOLPIDEM TARTRATEzolpidem tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-243ZOLPIDEM TARTRATEzolpidem tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-409ZOLPIDEM TARTRATEzolpidem tartrateMedsource PharmaceuticalsANDACurrent
45865-413ZOLPIDEM TARTRATEzolpidem tartrateMedsource PharmaceuticalsANDACurrent
50090-1022ZOLPIDEM TARTRATEzolpidem tartrateA-S Medication SolutionsANDACurrent
50090-1022ZOLPIDEM TARTRATEzolpidem tartrateA-S Medication SolutionsANDACurrent
50090-1022ZOLPIDEM TARTRATEzolpidem tartrateA-S Medication SolutionsANDACurrent
50090-1023ZOLPIDEM TARTRATEzolpidem tartrateA-S Medication SolutionsANDACurrent
50090-1023ZOLPIDEM TARTRATEzolpidem tartrateA-S Medication SolutionsANDACurrent
50436-0007ZOLPIDEM TARTRATEzolpidem tartrateUnit Dose ServicesANDACurrent
50436-0008ZOLPIDEM TARTRATEzolpidem tartrateUnit Dose ServicesANDACurrent
52959-879ZOLPIDEM TARTRATEZOLPIDEM TARTRATEH.J Harkins Company Inc.ANDACurrent
52959-879ZOLPIDEM TARTRATEZOLPIDEM TARTRATEH. J. Harkins Co., Inc.ANDACurrent
52959-880ZOLPIDEM TARTRATEzolpidem tartrateH.J. Harkins Company, Inc.ANDACurrent
53002-1292ZOLPIDEM TARTRATEzolpidem tartrateRPK Pharmaceuticals, Inc.ANDACurrent
53002-1292ZOLPIDEM TARTRATEzolpidem tartrateRPK Pharmaceuticals, Inc.ANDACurrent
53002-5020ZOLPIDEM TARTRATEzolpidem tartrateRPK Pharmaceuticals, Inc.ANDACurrent
53002-5020ZOLPIDEM TARTRATEzolpidem tartrateRPK Pharmaceuticals, Inc.ANDACurrent
55154-1398ZOLPIDEM TARTRATEzolpidem tartrateCardinal HealthANDACurrent
55154-1398ZOLPIDEM TARTRATEzolpidem tartrateCardinal HealthANDACurrent
55154-1398ZOLPIDEM TARTRATEzolpidem tartrateCardinal Health 107, LLCANDACurrent
55700-268ZOLPIDEM TARTRATEzolpidem tartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-268ZOLPIDEM TARTRATEzolpidem tartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-268ZOLPIDEM TARTRATEzolpidem tartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-357ZOLPIDEM TARTRATEzolpidem tartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-357ZOLPIDEM TARTRATEzolpidem tartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-357ZOLPIDEM TARTRATEzolpidem tartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-357ZOLPIDEM TARTRATEzolpidem tartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-357ZOLPIDEM TARTRATEzolpidem tartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-288ZOLPIDEM TARTRATEzolpidem tartrateSt. Mary's Medical Park PharmacyANDACurrent
60760-288ZOLPIDEM TARTRATEzolpidem tartrateSt. Mary's Medical Park PharmacyANDACurrent
60760-288ZOLPIDEM TARTRATEzolpidem tartrateSt. Mary's Medical Park PharmacyANDACurrent
60760-515ZOLPIDEM TARTRATEzolpidem tartrateSt Marys Medical Park PharmacyANDACurrent
60760-515ZOLPIDEM TARTRATEzolpidem tartrateSt Marys Medical Park PharmacyANDACurrent
60760-515ZOLPIDEM TARTRATEzolpidem tartrateSt Marys Medical Park PharmacyANDACurrent

Documents

DocumentSubmission typeDate
23891ORIG2007-08-24