FDA.reportPublic FDA data

Application 084935

Type
ANDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXEDRINEDEXTROAMPHETAMINE SULFATETABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084935-001DEXEDRINEDEXTROAMPHETAMINE SULFATE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dextroamphetamine sulfateDEXTROAMPHETAMINE SULFATEActavis Pharma, Inc.9e92ccc3-d81c-461d-a19f-7e9b582be3572026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
Dextroamphetamine Sulfate Extended-ReleaseDEXTROAMPHETAMINE SULFATESpecGx LLC69c40af8-3710-46bf-bd3d-137fe5eea23e2025-12-08Boxed warning, Warnings, Adverse reactionsName fallback
ZenzediDEXTROAMPHETAMINE SULFATEAzurity Pharmaceuticals, Inc.d6394df5-f2c9-47eb-b57e-f3e9cfd94f842025-11-26Boxed warning, Warnings, Adverse reactionsName fallback
DEXEDRINE SPANSULEDEXTROAMPHETAMINE SULFATEAmneal Pharmaceuticals LLCcc717b9b-22ea-4c60-a1d4-ee38a40bce782025-09-25Boxed warning, Warnings, Adverse reactionsName fallback
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack9346ff55-b751-4919-ae63-eb58b69e3f0f2025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack54b122b0-2ec8-43c9-86e8-a3538a83c7762025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack9f1c9cb0-7752-40cc-8ed1-5e79b8dc9da22025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepackfc164327-dd48-4851-b613-71d957ee60662025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEBryant Ranch Prepackb40c9a90-7e2e-48d6-adb6-2351c0ca621d2025-08-26Boxed warning, Warnings, Adverse reactionsName fallback
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATESpecGx LLCe05cf690-d45a-4696-a1bf-40c9350cc0842025-07-07Boxed warning, Warnings, Adverse reactionsName fallback
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEWinder Laboratories LLCca1a8890-0675-4c9c-9716-6c28f975d8272025-06-18Boxed warning, Warnings, Adverse reactionsName fallback
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEWilshire Pharmaceuticals, Inc.6b8c97ac-c83c-4a1f-a33c-121239253abf2025-06-13Boxed warning, Warnings, Adverse reactionsName fallback
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATETeva Pharmaceuticals USA, Inc.ec2d13f3-d14f-47e4-abe9-7763f95a8e942025-05-21Boxed warning, Warnings, Adverse reactionsName fallback
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATECranbury Pharmaceuticals, LLC9acdf000-fefe-47c7-a44c-0f7a65c5c05c2025-05-19Boxed warning, Warnings, Adverse reactionsName fallback
PROCENTRADEXTROAMPHETAMINE SULFATEINDEPENDENCE PHARMACEUTICALS, LLC1548cce2-fb6b-4f17-8a3b-868933f6c9d62025-05-14Boxed warning, Warnings, Adverse reactionsName fallback
Dextroamphetamine SulfateDEXTROAMPHETAMINE SULFATEPrasco Laboratories94674695-aa8a-3150-e053-2995a90a445f2025-05-01Boxed warning, Warnings, Adverse reactionsName fallback
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack466cbae8-4f67-4a65-b670-ada6a953d5502025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEBryant Ranch Prepack0ef920a9-c5b9-4d31-a478-ee18d22a3c5b2025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATESUNRISE PHARMACEUTICAL, INC.93b3a40f-b7ac-4047-8ff5-3e34c2d751932024-12-03Boxed warning, Warnings, Adverse reactionsName fallback
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEBryant Ranch Prepackc706a849-9df6-43ca-9ac6-1d9ce6b8e8552024-09-06Boxed warning, Warnings, Adverse reactionsName fallback

Boxed warning cross-check#

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boxed warning

WARNING: ABUSE, MISUSE, AND ADDICTION Dextroamphetamine sulfate extended-release capsule has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including d extroamphetamine sulfate extended-release capsules , can result in overdose and death [see Overdosage], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dextroamphetamine sulfate extended-release capsules , assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout dextroamphetamine sulfate extended-release capsules treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Drug Abuse and Dependence] .

Warnings cross-check#

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warnings

WARNINGS Abuse, Misuse, and Addiction Dextroamphetamine sulfate extended-release capsule has a high potential for abuse and misuse. The use of dextroamphetamine sulfate extended-release capsules exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dextroamphetamine sulfate extended-release capsules can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence] . Misuse and abuse of CNS stimulants, including dextroamphetamine sulfate extended-release capsules can result in overdose and death [see Overdosage] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dextroamphetamine sulfate extended-release capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give dextroamphetamine sulfate extended-release capsules to anyone else. Throughout dextroamphetamine sulfate extended-release capsules treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who are treated with CNS stimulants at the recommended ADHD dosages. Avoid dextroamphetamine sulfate extended-release capsule use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension. Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disease CNS stimulants may induce a manic or mixed episode in p...

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Cardiovascular Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and verbal tics, and Tourette’s syndrome. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia, and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects. Allergic Urticaria. Endocrine Impotence, changes in libido, frequent or prolonged erections. Musculoskeletal Rhabdomyolysis. Skin and Subcutaneous Tissue Disorders Alopecia. To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44406ORIG2007-05-18