FDA.report

Application 078327

Type
ANDA
Sponsor
AUROBINDO PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 25MG BASENoNo
002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 50MG BASENoNo
003SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 100MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-796SumatriptanSumatriptan SuccinateNorthStar Rx LLCANDACurrent
16714-796SumatriptanSumatriptan SuccinateNorthStar Rx LLCANDACurrent
16714-796SumatriptanSumatriptan SuccinateNorthStar Rx LLCANDACurrent
16714-797SumatriptanSumatriptan SuccinateNorthStar Rx LLCANDACurrent
16714-797SumatriptanSumatriptan SuccinateNorthStar Rx LLCANDACurrent
16714-797SumatriptanSumatriptan SuccinateNorthStar Rx LLCANDACurrent
16714-798SumatriptanSumatriptan SuccinateNorthStar Rx LLCANDACurrent
16714-798SumatriptanSumatriptan SuccinateNorthStar Rx LLCANDACurrent
16714-798SumatriptanSumatriptan SuccinateNorthStar Rx LLCANDACurrent
33261-663SumatriptanSumatriptan SuccinateAidarex Pharmaceuticals LLCANDACurrent
50090-1129SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1129SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1129SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1129SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1129SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1129SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1130SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1130SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1130SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1130SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1130SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1130SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-1130SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-2144SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-2144SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-2144SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-2144SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-2144SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50090-2144SumatriptanSumatriptan SuccinateA-S Medication SolutionsANDACurrent
50436-0147SumatriptanSumatriptan SuccinateUnit Dose ServicesANDACurrent
53002-1562SumatriptanSumatriptan SuccinateRPK Pharmaceuticals, Inc.ANDACurrent
53002-1562SumatriptanSumatriptan SuccinateRPK Pharmaceuticals, Inc.ANDACurrent
53002-2592SumatriptanSumatriptan SuccinateRPK Pharmaceuticals, Inc.ANDACurrent
53002-2592SumatriptanSumatriptan SuccinateRPK Pharmaceuticals, Inc.ANDACurrent
53002-2593SumatriptanSumatriptan SuccinateRPK Pharmaceuticals, Inc.ANDACurrent
53002-2593SumatriptanSumatriptan SuccinateRPK Pharmaceuticals, Inc.ANDACurrent
55700-759SumatriptanSumatriptan SuccinateQuality Care Products, LLCANDACurrent
55700-759SumatriptanSumatriptan SuccinateQuality Care Products, LLCANDACurrent
55700-889SumatriptanSumatriptan SuccinateQuality Care Products, LLCANDACurrent
55700-899SumatriptanSumatriptan SuccinateQuality Care Products, LLCANDACurrent
55700-936SumatriptanSumatriptan SuccinateQuality Care Products, LLCANDACurrent
55700-936SumatriptanSumatriptan SuccinateQuality Care Products, LLCANDACurrent
61919-300SUMATRIPTANsumatriptan succinate tabletDIRECT RXANDACurrent
61919-950IMITREXSUMATRIPTANDIRECTRXANDACurrent
63187-797SumatriptanSumatriptan SuccinateProficient Rx LPANDACurrent
63187-797SumatriptanSumatriptan SuccinateProficient Rx LPANDACurrent
63187-797SumatriptanSumatriptan SuccinateProficient Rx LPANDACurrent
63187-797SumatriptanSumatriptan SuccinateProficient Rx LPANDACurrent
63187-931SumatriptanSumatriptan SuccinateProficient Rx LPANDACurrent
63187-931SumatriptanSumatriptan SuccinateProficient Rx LPANDACurrent
63187-969SumatriptanSumatriptan SuccinateProficient Rx LPANDACurrent
63187-969SumatriptanSumatriptan SuccinateProficient Rx LPANDACurrent
63187-969SumatriptanSumatriptan SuccinateProficient Rx LPANDACurrent
63187-969SumatriptanSumatriptan SuccinateProficient Rx LPANDACurrent
63629-8134SumatriptanSumatriptan SuccinateBryant Ranch PrepackANDACurrent
63629-8188SumatriptanSumatriptan SuccinateBryant Ranch PrepackANDACurrent
63629-8188SumatriptanSumatriptan SuccinateBryant Ranch PrepackANDACurrent
65862-146SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-146SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-146SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-146SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-146SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-147SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-147SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-147SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-147SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-147SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-148SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-148SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-148SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-148SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
65862-148SumatriptanSumatriptan SuccinateAurobindo Pharma LimitedANDACurrent
68071-3350SumatriptanSumatriptan SuccinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3350SumatriptanSumatriptan SuccinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4061SumatriptanSumatriptan Succinate U-DNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4061SumatriptanSumatriptan Succinate U-DNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4815SumatriptanSumatriptan SuccinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4815SumatriptanSumatriptan SuccinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5072SumatriptanSumatriptan SuccinateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5072SumatriptanSumatriptan SuccinateNuCare Pharmaceuticals,Inc.ANDACurrent

Documents

DocumentSubmission typeDate
9143ORIG2009-08-14