FDA.reportPublic FDA data

Application 040268

Type
ANDA
Sponsor
JUBILANT CADISTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCOMPPROCHLORPERAZINE MALEATETABLET;ORALEQ 5MG BASENoNo
002PROCOMPPROCHLORPERAZINE MALEATETABLET;ORALEQ 10MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-8190PROCHLORPERAZINE MALEATEProchlorperazine MaleateLiberty Pharmaceuticals, Inc.ANDACurrent
10544-281PROCHLORPERAZINE MALEATEProchlorperazine maleateBlenheim Pharmacal, Inc.ANDACurrent
10544-511PROCHLORPERAZINE MALEATEProchlorperazine MaleateBlenheim Pharmacal, Inc.ANDACurrent
21695-571PROCHLORPERAZINE MALEATEProchlorperazine MaleateRebel Distributors CorpANDACurrent
21695-572PROCHLORPERAZINE MALEATEProchlorperazine maleateRebel Distributors CorpANDACurrent
33261-141PROCHLORPERAZINE MALEATEProchlorperazine MaleateAidarex Pharmaceuticals LLCANDACurrent
33261-550PROCHLORPERAZINE MALEATEProchlorperazine maleateAidarex Pharmaceuticals LLCANDACurrent
42291-728PROCHLORPERAZINE MALEATEProchlorperazine MaleateAvKAREANDACurrent
42291-728PROCHLORPERAZINE MALEATEProchlorperazine MaleateAvKAREANDACurrent
42291-729PROCHLORPERAZINE MALEATEProchlorperazine maleateAvKAREANDACurrent
42291-729PROCHLORPERAZINE MALEATEProchlorperazine maleateAvKAREANDACurrent
42708-103Prochlorperazine maleateProchlorperazine maleateQPharma IncANDACurrent
42708-103Prochlorperazine maleateProchlorperazine maleateQPharma IncANDACurrent
43063-742PROCHLORPERAZINE MALEATEProchlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-742PROCHLORPERAZINE MALEATEProchlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-742PROCHLORPERAZINE MALEATEProchlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-742PROCHLORPERAZINE MALEATEProchlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-742PROCHLORPERAZINE MALEATEProchlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-742PROCHLORPERAZINE MALEATEProchlorperazine maleatePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2241PROCHLORPERAZINE MALEATEProchlorperazine MaleateA-S Medication SolutionsANDACurrent
50090-2241PROCHLORPERAZINE MALEATEProchlorperazine MaleateA-S Medication SolutionsANDACurrent
50090-2242PROCHLORPERAZINE MALEATEProchlorperazine MaleateA-S Medication SolutionsANDACurrent
50090-2242PROCHLORPERAZINE MALEATEProchlorperazine MaleateA-S Medication SolutionsANDACurrent
50090-2242PROCHLORPERAZINE MALEATEProchlorperazine MaleateA-S Medication SolutionsANDACurrent
50090-2242PROCHLORPERAZINE MALEATEProchlorperazine MaleateA-S Medication SolutionsANDACurrent
50090-2839PROCHLORPERAZINE MALEATEProchlorperazine maleateA-S Medication SolutionsANDACurrent
50090-2839PROCHLORPERAZINE MALEATEProchlorperazine maleateA-S Medication SolutionsANDACurrent
50090-2839PROCHLORPERAZINE MALEATEProchlorperazine maleateA-S Medication SolutionsANDACurrent
50268-684PROCHLORPERAZINE MALEATEProchlorperazine MaleateAvPAKANDACurrent
50268-684PROCHLORPERAZINE MALEATEProchlorperazine MaleateAvPAKANDACurrent
50268-685PROCHLORPERAZINE MALEATEProchlorperazine maleateAvPAKANDACurrent
50268-685PROCHLORPERAZINE MALEATEProchlorperazine maleateAvPAKANDACurrent
51655-096Prochlorperazine MaleateProchlorperazine MaleateNorthwind PharmaceuticalsANDACurrent
54348-114PROCHLORPERAZINEPROCHLORPERAZINEPharmPak, Inc.ANDACurrent
54348-114PROCHLORPERAZINEPROCHLORPERAZINEPharmPak, Inc.ANDACurrent
54348-989ProchlorperazinePROCHLORPERAZINEPharmPak, Inc.ANDACurrent
54348-989ProchlorperazinePROCHLORPERAZINEPharmPak, Inc.ANDACurrent
55154-4342PROCHLORPERAZINE MALEATEProchlorperazine maleateCardinal HealthANDACurrent
55154-4342PROCHLORPERAZINE MALEATEProchlorperazine maleateCardinal HealthANDACurrent
55154-4342PROCHLORPERAZINE MALEATEProchlorperazine maleateCardinal Health 107, LLCANDACurrent
59746-113PROCHLORPERAZINE MALEATEProchlorperazine MaleateJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
59746-115PROCHLORPERAZINE MALEATEProchlorperazine maleateJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
61919-327PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEDIRECT RXANDACurrent
61919-908PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEDIRECT RXANDACurrent
61919-908PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEDirect_RxANDACurrent
63187-251PROCHLORPERAZINE MALEATEProchlorperazine maleateProficient Rx LPANDACurrent
63187-251PROCHLORPERAZINE MALEATEProchlorperazine maleateProficient Rx LPANDACurrent
63187-251PROCHLORPERAZINE MALEATEProchlorperazine maleateProficient Rx LPANDACurrent
63187-502PROCHLORPERAZINE MALEATEProchlorperazine MaleateProficient Rx LPANDACurrent
63187-502PROCHLORPERAZINE MALEATEProchlorperazine MaleateProficient Rx LPANDACurrent
63187-502PROCHLORPERAZINE MALEATEProchlorperazine MaleateProficient Rx LPANDACurrent
63629-1841PROCHLORPERAZINE MALEATEProchlorperazine MaleateBryant Ranch PrepackANDACurrent
63629-1841PROCHLORPERAZINE MALEATEProchlorperazine MaleateBryant Ranch PrepackANDACurrent
66267-271PROCHLORPERAZINE MALEATEProchlorperazine MaleateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-271PROCHLORPERAZINE MALEATEProchlorperazine MaleateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-271PROCHLORPERAZINE MALEATEProchlorperazine MaleateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-271PROCHLORPERAZINE MALEATEProchlorperazine MaleateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-318PROCHLORPERAZINE MALEATEProchlorperazine maleateNuCare Pharmaceuticals,Inc.ANDACurrent
66267-318PROCHLORPERAZINE MALEATEProchlorperazine maleateNuCare Pharmaceuticals,Inc.ANDACurrent
66267-826PROCHLORPERAZINE MALEATEProchlorperazine MaleateNuCare Pharmaceuticals,Inc.ANDACurrent
66267-826PROCHLORPERAZINE MALEATEProchlorperazine MaleateNuCare Pharmaceuticals,Inc.ANDACurrent
66336-921PROCHLORPERAZINE MALEATEProchlorperazine maleateDispensing Solutions, Inc.ANDACurrent
67296-0238PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedPharm Drug, Inc.ANDACurrent
67296-0238PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedPharm Drug, Inc.ANDACurrent
67296-0238PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedPharm Drug, Inc.ANDACurrent
67296-0727PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedPharm Drug, Inc.ANDACurrent
67296-0727PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedPharm Drug, Inc.ANDACurrent
67296-0727PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedPharm Drug, Inc.ANDACurrent
68788-7628PROCHLORPERAZINE MALEATEProchlorperazine maleateJUBILANT CADISTA PHARMACEUTICALS INC.ANDACurrent
68788-7628PROCHLORPERAZINE MALEATEProchlorperazine maleatePreferred Pharmaceuticlas Inc.ANDACurrent
68788-7628PROCHLORPERAZINE MALEATEProchlorperazine maleatePreferred Pharmaceuticlas Inc.ANDACurrent
70518-1620PROCHLORPERAZINE MALEATEProchlorperazine maleateREMEDYREPACK INC.ANDACurrent
70518-1620PROCHLORPERAZINE MALEATEProchlorperazine maleateREMEDYREPACK INC.ANDACurrent
70518-1620PROCHLORPERAZINE MALEATEProchlorperazine maleateREMEDYREPACK INC.ANDACurrent
70518-1620PROCHLORPERAZINE MALEATEProchlorperazine maleateREMEDYREPACK INC.ANDACurrent
70518-1620PROCHLORPERAZINE MALEATEProchlorperazine maleateREMEDYREPACK INC.ANDACurrent
70518-1620PROCHLORPERAZINE MALEATEProchlorperazine maleateREMEDYREPACK INC.ANDACurrent
70934-405PROCHLORPERAZINE MALEATEProchlorperazine MaleateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-405PROCHLORPERAZINE MALEATEProchlorperazine MaleateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-419PROCHLORPERAZINE MALEATEProchlorperazine maleateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82188SUPPL 2025-05-15
82128SUPPL 2025-05-01
42605ORIG1998-02-27