FDA.reportPublic FDA data

Application 209755

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo
004CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL100MGNoNo
005CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL200MGNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209755-001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE10MGTABLET / ORALAB2018-09-10
A209755-002CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE25MGTABLET / ORALAB2018-09-10
A209755-003CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE50MGTABLET / ORALAB2018-09-10
A209755-004CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE100MGTABLET / ORALAB2018-09-10
A209755-005CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDE200MGTABLET / ORALAB2018-09-10

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A209755-001AB
A209755-002AB
A209755-003AB
A209755-004AB
A209755-005AB

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCaa086a21-de85-4b03-af58-49b70acf8cf02026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAK9e8cebc0-7fcf-dca8-e053-2a95a90a33692026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health Packagingd43718e5-66d7-44f9-9fc8-80d38d3e41ce2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

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boxed warning

WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).

Warnings cross-check#

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warnings

WARNINGS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). The extrapyramidal symptoms which can occur secondary to chlorpromazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye's syndrome or other encephalopathy. The use of chlorpromazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye's syndrome. Tardive Dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and therapy may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Given these considerations, antipsychotics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and, 2) for w...

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Note: Some adverse effects of chlorpromazine may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses. Drowsiness: Usually mild to moderate, may occur, particularly during the first or second week, after which it generally disappears. If troublesome, dosage may be lowered. Jaundice: Overall incidence has been low, regardless of indication or dosage. Most investigators conclude it is a sensitivity reaction. Most cases occur between the second and fourth weeks of therapy. The clinical picture resembles infectious hepatitis, with laboratory features of obstructive jaundice, rather than those of parenchymal damage. It is usually promptly reversible on withdrawal of the medication; however, chronic jaundice has been reported. There is no conclusive evidence that pre-existing liver disease makes patients more susceptible to jaundice. Alcoholics with cirrhosis have been successfully treated with chlorpromazine without complications. Nevertheless, the medication should be used cautiously in patients with liver disease. Patients who have experienced jaundice with a phenothiazine should not, if possible, be reexposed to chlorpromazine or other phenothiazines. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. Liver function tests in jaundice induced by the drug may mimic extrahepatic obstruction; withhold exploratory laparotomy until extrahepatic obstruction is confirmed. Hematological Disorders: including agranulocytosis, eosinophilia, leukopenia, hemolytic anemia, aplastic anemia, thrombocytopenic purpura and pancytopenia have been reported. Agranulocytosis – Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate cellular depression, stop treatment and start antibiotic and other suitable therapy. Most cases have occurred between the fourth and tenth weeks of therapy; patients should be watched closely during that period. Moderate suppression of white blood cells is not an indication for stopping treatment unless accompanied by the symptoms described above. Cardiovascular: Hypotensive Effects – Postural...

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6892CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6892CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6892CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6892CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6893CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6893CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6893CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6894CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6894CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6894CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6894CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6894CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6895CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6895CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6895CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6895CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6895CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6896CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6896CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6896CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6896CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-6896CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
50268-162CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-162CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-162CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-163CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-163CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-163CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-164CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-164CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-164CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-165CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-165CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-165CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-166CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-166CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
50268-166CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAKANDACurrent
60687-419CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-419CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-419CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-430CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-430CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-430CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-441CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-441CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-441CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-452CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-452CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-452CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-463CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-463CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
60687-463CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmerican Health PackagingANDACurrent
69238-1054CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1054CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1054CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1054CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals LLCANDACurrent
69238-1054CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1056CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1056CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1056CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals LLCANDACurrent
69238-1056CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1056CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1058CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1058CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1058CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1058CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals LLCANDACurrent
69238-1058CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1060CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1060CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1060CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals LLCANDACurrent
69238-1060CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1060CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1062CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1062CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1062CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1062CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals LLCANDACurrent
69238-1062CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCANDACurrent
70518-3321CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent