FDA.reportPublic FDA data

Application 040613

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATESYRUP;ORAL1.5MG/5ML;5MG/5MLNoYes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040613-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE1.5MG/5ML;5MG/5MLSYRUP / ORAL2008-02-08

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTIONKVK-Tech, Inc.9a737416-08e0-4df6-897e-cf9d1b5f0b012026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEGenus Lifesciences Inc.320ff639-9854-407b-9bbd-a035c4f173e12026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEPAI Holdings, LLC dba PAI Pharma71319a6f-aaf4-4bc5-8b40-a16c6f139be62026-02-28Boxed warning, Warnings, Adverse reactionsName fallback
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEKVK-Tech, Inc.26d7c90c-5e6b-4bdb-b06f-c76173a01c212026-01-06Boxed warning, Warnings, Adverse reactionsName fallback
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDENovel Laboratories, Inc.4050ae05-7f1a-48b7-99b9-f8db8aa027412024-10-08Boxed warning, Warnings, Adverse reactionsName fallback
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDELupin Pharmaceuticals,Inc.41ac90b3-f007-4eb2-9d41-ea626ced20172024-09-12Boxed warning, Warnings, Adverse reactionsName fallback
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDENovel Laboratories, Inc.b203c87c-1108-4eaa-8a57-87be776d8a702023-12-12Boxed warning, Warnings, Adverse reactionsName fallback

Boxed warning cross-check#

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boxed warning

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME Addiction, Abuse, and Misuse Hydrocodone bitartrate and homatropine methylbromide exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing hydrocodone bitartrate and homatropine methylbromide, prescribe hydrocodone bitartrate and homatropine methylbromide for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment [see Warnings and Precautions (5.1)] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and homatropine methylbromide. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and homatropine methylbromide therapy or when used in patients at higher risk [see Warnings and Precautions (5.2)] . Accidental Ingestion Accidental ingestion of even one dose of hydrocodone bitartrate and homatropine methylbromide, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions (5.2)] . Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate and homatropine methylbromide. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering hydrocodone bitartrate and homatropine methylbromide [see Dosage and Administration (2.1), Warnings and Precautions (5.5)] . Cytochrome P450 3A4 Interaction The concomitant use of hydrocodone bitartrate and homatropine methylbromide with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, ...

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor closely, particularly during initiation of therapy. (5.4) Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. (5.6) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors: Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. (5.10) Seizures in patients with seizure disorders: Monitor during therapy. (5.11) Severe hypotension: Monitor during initiation of therapy. Avoid use in patients with circulatory shock. (5.12) Adrenal insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.14) 5.1 Addiction, Abuse, and Misuse Hydrocodone bitartrate and homatropine methylbromide contains hydrocodone, a Schedule II controlled substance. As an opioid, hydrocodone bitartrate and homatropine methylbromide exposes users to the risks of addiction, abuse, and misuse [ see Drug Abuse and Dependence (9)], which can lead to overdose and death [see Overdosage (10)] . Reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing hydrocodone bitartrate and homatropine methylbromide, prescribe hydrocodone bitartrate and homatropine methylbromide for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and homatropine methylbromide. Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fat...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Addiction, abuse, and misuse [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.3)] Life-threatening respiratory depression [see Warnings and Precautions (5.2, 5.3, 5.4, 5.8), Overdosage (10)] Accidental overdose and death due to medication errors [see Warnings and Precautions (5.5)] Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.6)] Interactions with benzodiazepines and other CNS depressants [see Warnings and Precautions (5.8), Drug Interactions (7.1, 7.4)] Paralytic ileus, gastrointestinal adverse reactions [see Warnings and Precautions (5.9)] Increased intracranial pressure [see Warnings and Precautions (5.10)] Obscured clinical course in patients with head injuries [see Warnings and Precautions (5.10)] Seizures [see Warnings and Precautions (5.11)] Severe hypotension [see Warnings and Precautions (5.12)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.13)] Adrenal insufficiency [see Warnings and Precautions (5.14)] The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of hydrocodone and/or homatropine. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to hydrocodone bitartrate and homatropine methylbromide include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation. Other reactions include: Anaphylaxis: Anaphylaxis has been reported with hydrocodone, one of the ingredients in hydrocodone bitartrate and homatropine methylbromide. Body as a whole: Coma, death, fatigue, falling injuries, lethargy. Cardiovascular: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush. Central Nervous System: Facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor. Dermatologic: Flushing, hyperhidrosis, pruritus, rash. Endocrine/Metabolic: C...

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0043Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideAtlantic Biologicals CorpsANDACurrent
21695-869Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideRebel Distributors CorpANDACurrent
50383-043Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide101196749ANDACurrent
50383-043Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-043Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideAkornANDACurrent