FDA.reportPublic FDA data

Application 040419

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;15MGNoYes
002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;30MGNoNo
003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;60MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0483ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
0406-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateSpecGx LLCANDACurrent
10544-032ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBlenheim Pharmacal, Inc.ANDACurrent
21695-242ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateRebel Distributors Corp.ANDACurrent
21695-243ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateRebel Distributors Corp.ANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-026ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateQuality Care Products LLCANDACurrent
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATELake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATELake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATELake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATELake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-060ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATELake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-3011ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-3011ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-3011ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-3871ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-3871ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-4610ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-4610ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-4611ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-4611ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
53217-370ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateAidarex Pharmaceuticals LLCANDACurrent
55045-1580ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateDispensing Solutions, Inc.ANDACurrent
55154-7553ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateCardinal HealthANDACurrent
55154-7553ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateCardinal Health 107, LLCANDACurrent
55154-7553ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateCardinal HealthANDACurrent
55154-7553ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateCardinal HealthANDACurrent
55154-7553ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateCardinal HealthANDACurrent
58118-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
58118-0485ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
58118-4484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
58118-4484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
58118-4484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
58118-4484ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateClinical Solutions Wholesale, LLCANDACurrent
60760-581ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateST. MARY'S MEDICAL PARK PHARMACYANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDIRECT RXANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-484ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateProficient Rx LPANDACurrent
63629-3031ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-3031Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateBryant Ranch PrepackANDACurrent
63629-3031Acetaminophen and Codeine Phosphateacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
67046-886ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphatecoupler enterprises inc.ANDACurrent
67046-901ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateContract Pharmacy Services-PAANDACurrent
67296-0065ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATERedPharm DrugANDACurrent
67296-0065ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATERedPharm DrugANDACurrent
67296-0065ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATERedPharm DrugANDACurrent
67544-002ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-002ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-003ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-003ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-2800ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76179ORIG 2023-11-03
29952ORIG2001-05-31