FDA.reportPublic FDA data

Application 088760

Type
ANDA
Sponsor
BRISTOL MYERS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEXATE-AQMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 25MG BASE/MLNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088760-001MEXATE-AQMETHOTREXATE SODIUMEQ 25MG BASE/MLINJECTABLE / INJECTIONRLD1985-02-14

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
Methotrexate SodiumMETHOTREXATE SODIUMElite Laboratories, Inc.89c05ea3-3be1-46dd-b112-29c436fd72892026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
MethotrexateMETHOTREXATE SODIUMSun Pharmaceutical Industries, Inc.8f1260de-b60c-4f0e-8af6-0e957b0a281b2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
Methotrexate SodiumMETHOTREXATE SODIUMHikma Pharmaceuticals USA Inc.d71b1856-99d8-4a9e-9189-f87b6675f80a2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
MethotrexateMETHOTREXATE SODIUMFresenius Kabi USA, LLCec476b11-0b3c-4139-b1eb-a3daa76bc2712025-08-19Boxed warning, Warnings, Adverse reactionsName fallback
MethotrexateMETHOTREXATE SODIUMBryant Ranch Prepackc7592288-ac24-46c6-8cec-9abe23d7e81e2023-12-07Boxed warning, Warnings, Adverse reactionsName fallback
MethotrexateMETHOTREXATE SODIUMFresenius Kabi USA, LLCb585f621-f6c9-4735-ab61-bd1b401f3df02021-03-24Boxed warning, Adverse reactionsName fallback

Boxed warning cross-check#

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boxed warning

WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS , SEVERE ADVERSE REACTIONS, and RISK OF MEDICATION ERRORS Methotrexate Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications (4) , Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] . Methotrexate Tablets are contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] . Methotrexate tablets when inadvertently administered once daily have resulted in death ( 5.9 ). Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Methotrexate Tablets as appropriate [Warnings and Precautions ( 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 )] . WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, SEVERE ADVERSE REACTIONS, and RISK OF MEDICATION ERRORS See full prescribing information for complete boxed warning. Methotrexate Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are contraindicated in pregnancy. For neoplastic diseases, advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 4 , 5.1 , 8.1 , 8.3 ) Methotrexate Tablets are contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis. ( 4 , 5.2 ) Methotrexate tablets when inadvertently administered once daily have resulted in death ( 5.9 ) Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Methotrexate Tablets as appropriate. ( 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 )

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS • Serious Infections : Monitor patients for infection during and after treatment with Methotrexate Tablets. Withhold or discontinue Methotrexate Tablets for serious infections as appropriate. ( 5.11 ) • Neurotoxicity : Monitor patients for neurotoxicity and withhold or discontinue Methotrexate Tablets as appropriate. ( 5.12 ) • Secondary Malignancies : Can occur with methotrexate. ( 5.13 ) • Tumor Lysis Syndrome : Institute appropriate prophylactic measures in patients at risk for tumor lysis syndrome prior to initiation of Methotrexate Tablets. ( 5.14 ) • Immunizations and Risk Live Vaccines : Immunizations with live vaccines is not recommended. Follow current vaccination practice guidelines. ( 5.15 ) • Infertility : Can cause impairment of fertility, oligospermia, and menstrual dysfunction. ( 5.16 , 8.3 ) 5.1 Embryo-Fetal Toxicity Based on published reports and its mechanism of action, Methotrexate Tablets can cause fetal harm, including fetal death, when administered to a pregnant woman. Methotrexate Tablets is contraindicated for use in pregnant women receiving Methotrexate Tablets for the treatment of non-malignant diseases. Advise pregnant women with neoplastic diseases of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Methotrexate Tablets and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during Methotrexate Tablets treatment and for 3 months after the final dose [see Contraindications ( 4 ), Use in Specific Populations ( 8.1 , 8.3 )]. 5.2 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, can occur with methotrexate [see Contraindications ( 4 ), Adverse Reactions ( 6.1 )]. If anaphylaxis or other serious hypersensitivity reaction occurs, immediately and permanently discontinue Methotrexate Tablets [see Dosage and Administration ( 2.6 )]. 5.3 Myelosuppression Methotrexate suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia [see Adverse Reactions ( 6.1 )]. Obtain blood counts at baseline, periodically during treatment, and as clinically indicated. Monitor patients for clinical complications of myelosuppression. Withhold, dose reduce, or discontinue Methotrexate...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] • Myelosuppression [see Warnings and Precautions ( 5.3 )] • Gastrointestinal Toxicity [see Warnings and Precautions ( 5.4 )] • Hepatotoxicity [see Warnings and Precautions ( 5.5 )] • Pulmonary Toxicity [see Warnings and Precautions ( 5.6 )] • Dermatologic Reactions [see Warnings and Precautions ( 5.7 )] • Renal Toxicity [see Warnings and Precautions ( 5.8 )] • Serious Infections [see Warnings and Precautions ( 5.11 )] • Neurotoxicity [see Warnings and Precautions ( 5.12 )] • Secondary Malignancies [see Warnings and Precautions ( 5.13 )] • Tumor Lysis Syndrome [see Warnings and Precautions ( 5.14 )] • Increased Risk of Adverse Reactions Due to Third-Space Accumulation [see Warnings and Precautions ( 5.17 )] Common adverse reactions include ulcerative stomatitis, leukopenia, nausea, abdominal distress. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Elite Laboratories, Inc . at 1-888-852-6657 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials and other studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Common adverse reactions were: ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other clinically relevant adverse reactions were infection, malaise, fatigue, chills, fever, and dizziness. Rheumatoid Arthritis The most common adverse reactions of methotrexate that exceeded the rate of placebo in 12- to 18-week double-blind studies in patients (n=128) with rheumatoid arthritis are listed below. Patients received methotrexate 7.5 to 15 mg orally once weekly. Most patients received concomitant nonsteroidal anti-inflammatory drugs (NSAIDs) and some also received corticosteroids. Hepatic histology was not examined in these short-term studies. Incidence ≥10%: Elevated liver tests 15%, nausea/vomiting 10% Incidence 3% to