FDA.reportPublic FDA data

Application 084050

Type
ANDA
Sponsor
NEXGEN PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISONIAZIDISONIAZIDTABLET;ORAL100MGNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084050-001ISONIAZIDISONIAZID100MGTABLET / ORALApproved before 1982

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
isoniazidISONIAZIDREMEDYREPACK INC.93252cc8-c8d4-401b-bde5-ca8a3b57651e2026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDBryant Ranch Prepack03bf3bd5-64f9-4491-89fd-96c5c10d01292026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDREMEDYREPACK INC.6dab7b7b-a3a9-47ef-b423-134bc6970d8b2026-01-05Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDChartwell RX, LLC8a6fa0b2-48e3-4c06-97c5-9ec3d6475a7c2025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
isoniazidISONIAZIDCoupler LLC44592c5c-d11c-148d-e063-6294a90ab35c2025-11-24Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDBryant Ranch Prepackb6d6dccc-2577-4bbb-896e-5f75b65ee6ca2025-10-13Boxed warning, Warnings, Adverse reactionsName fallback
isoniazidISONIAZIDA-S Medication Solutionsed780e28-a2c3-44dc-898a-d2cbe05eeedf2025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
isoniazidISONIAZIDMarlex Pharmaceuticals, Inc.312cd403-b211-64ef-e063-6394a90aab882025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDBryant Ranch Prepack9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c2025-08-08Boxed warning, Warnings, Adverse reactionsName fallback
isoniazidISONIAZIDOMNIVIUM PHARMACEUTICALS LLC.35400f1d-fd25-4bfa-a382-ac390e21bf2e2025-07-08Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDCoupler LLC38f4c4af-81da-9b0c-e063-6294a90a8b9d2025-07-02Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDGenus Lifesciencesf0b46d1d-2300-457d-a7bd-a88a3f8d22352025-06-30Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDA-S Medication Solutionsd5039796-6ba0-4fa8-84f7-e47c63d451632025-04-02Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDSandoz Inc77795c31-1cdf-4a20-b4a1-cd15f5b310f12025-02-24Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDChartwell RX, LLC2e09b1a5-9786-427f-bf00-be15b06eb7e72025-02-12Boxed warning, Warnings, Adverse reactionsName fallback
isoniazidISONIAZIDBryant Ranch Prepackeeaf09a3-5631-4089-9f17-15750c002e322025-02-12Boxed warning, Warnings, Adverse reactionsName fallback
isoniazidISONIAZIDBryant Ranch Prepack63bf1fe0-5d74-4123-88b7-a95d521befca2025-02-12Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDMylan Institutional Inc.60a6b514-fa7f-4bc7-85b0-e5a14fa56b592025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDCMP Pharma, Inc.db8a3ae7-fb5b-47a9-a9f7-f57cd90501c22024-11-07Boxed warning, Warnings, Adverse reactionsName fallback
IsoniazidISONIAZIDA-S Medication Solutions8a309582-1bb7-4b21-af43-c38710ac83d52023-06-02Boxed warning, Warnings, Adverse reactionsName fallback

Boxed warning cross-check#

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boxed warning

WARNING Severe and sometimes fatal hepatitis associated with isoniazid therapy has been reported and may occur or may develop even after many months of treatment. The risk of developing hepatitis is age related. Approximate case rates by age are: less than 1 per 1,000 for persons under 20 years of age, 3 per 1,000 for persons in the 20 to 34 year age group, 12 per 1,000 for persons in the 35 to 49 year age group, 23 per 1,000 for persons in the 50 to 64 year age group and 8 per 1,000 for persons over 65 years of age. The risk of hepatitis is increased with daily consumption of alcohol. Precise data to provide a fatality rate for isoniazid-related hepatitis is not available; however, in a U.S. Public Health Service Surveillance Study of 13,838 persons taking isoniazid, there were 8 deaths among 174 cases of hepatitis. Therefore, patients given isoniazid should be carefully monitored and interviewed at monthly intervals. For persons 35 and older, in addition to monthly symptom reviews, hepatic enzymes (specifically, AST and ALT (formerly SGOT and SGPT, respectively)) should be measured prior to starting isoniazid therapy and periodically throughout treatment. Isoniazid-associated hepatitis usually occurs during the first three months of treatment. Usually, enzyme levels return to normal despite continuance of drug, but in some cases progressive liver dysfunction occurs. Other factors associated with an increased risk of hepatitis include daily use of alcohol, chronic liver disease and injection drug use. A recent report suggests an increased risk of fatal hepatitis associated with isoniazid among women, particularly black and Hispanic women. The risk may also be increased during the post-partum period. More careful monitoring should be considered in these groups, possibly including more frequent laboratory monitoring. If abnormalities of liver function exceed three to five times the upper limit of normal, discontinuation of isoniazid should be strongly considered. Liver function tests are not a substitute for a clinical evaluation at monthly intervals or for the prompt assessment of signs or symptoms of adverse reactions occurring between regularly scheduled evaluations. Patients should be instructed to immediately report signs or symptoms consistent with liver damage or other adverse effects. These include any of the following: unexplained anorexia, nausea...

Warnings cross-check#

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warnings

WARNINGS See the boxed warning. Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of isoniazid (see ADVERSE REACTIONS). Symptoms can be serious and potentially life threatening. If symptoms or signs of SCARs develop, discontinue isoniazid tablets immediately and institute appropriate therapy. Cerebellar Syndrome Cerebellar syndrome which may include abnormal motor coordination presenting as gait, trunk, and limb ataxia, dysmetria and dysdiadochokinesia, intention tremor, dysarthria, or nystagmus, has been reported in postmarketing case reports with the use of isoniazid (see ADVERSE REACTIONS). Most cases of cerebellar syndrome involved patients with chronic kidney disease (CKD), however, cerebellar syndrome was also reported in patients without CKD. Discontinue isoniazid tablets if symptoms or signs of cerebellar syndrome occur.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS The most frequent reactions are those affecting the nervous system and the liver. Nervous System Reactions: Peripheral neuropathy is the most common toxic effect. It is dose-related, occurs most often in the malnourished and in those predisposed to neuritis (e.g., alcoholics and diabetics), and is usually preceded by paresthesias of the feet and hands. The incidence is higher in "slow inactivators". Cerebellar syndrome, which may include abnormal motor coordination manifesting as gait, trunk, and limb ataxia, dysmetria and dysdiadochokinesia, intention tremor, dysarthria, or nystagmus, have been reported in post marketing case reports (see WARNINGS). Other neurotoxic effects, which are uncommon with conventional doses, are convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment and toxic psychosis. Hepatic Reactions: See boxed warning. Elevated serum transaminase (SGOT; SGPT), bilirubinemia, bilirubinuria, jaundice, and occasionally severe and sometimes fatal hepatitis. The common prodromal symptoms of hepatitis are anorexia, nausea, vomiting, fatigue, malaise, and weakness. Mild hepatic dysfunction, evidenced by mild and transient elevation of serum transaminase levels occurs in 10 to 20 percent of patients taking isoniazid. This abnormality usually appears in the first 1 to 3 months of treatment but can occur at any time during therapy. In most instances, enzyme levels return to normal, and generally, there is no necessity to discontinue medication during the period of mild serum transaminase elevation. In occasional instances, progressive liver damage occurs, with accompanying symptoms. If the SGOT value exceeds three to five times the upper limit of normal, discontinuation of the isoniazid should be strongly considered. The frequency of progressive liver damage increases with age. It is rare in persons under 20, but occurs in up to 2.3 percent of those over 50 years of age. Gastrointestinal Reactions: Nausea, vomiting and epigastric distress. Hematologic Reactions: Agranulocytosis; hemolytic, sideroblastic or aplastic anemia, thrombocytopenia and eosinophilia. Hypersensitivity Reactions: Fever, skin eruptions (morbilliform, maculopapular, purpuric, or exfoliative), lymphadenopathy, vasculitis, acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis, and dr...