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This document contains the approval package for Promethazine Hydrochloride Injection, including safety labeling, warnings, discussions regarding dosage and administration, and regulatory correspondence
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How to fill out approval package for promethazine
How to fill out Approval Package for Promethazine Hydrochloride Injection
01
Gather all necessary documentation and forms required for the Approval Package.
02
Fill out the application form with accurate product information, including dosage form, strength, and indications for use.
03
Provide a detailed description of the manufacturing process for Promethazine Hydrochloride Injection.
04
Include stability data demonstrating the product's shelf life and storage conditions.
05
Attach any relevant clinical data or studies supporting the safety and efficacy of the drug.
06
Ensure all sections of the package are completed and double-check for accuracy.
07
Submit the completed Approval Package to the appropriate regulatory authority.
Who needs Approval Package for Promethazine Hydrochloride Injection?
01
Pharmaceutical companies seeking to market Promethazine Hydrochloride Injection.
02
Manufacturers requiring regulatory approval to distribute the injection.
03
Healthcare providers who need information on filing for necessary medications.
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People Also Ask about
What are side effects of promethazine injection?
Side Effects Convulsions (seizures) difficult or unusually fast breathing. fast heartbeat or irregular pulse. high fever. high or low blood pressure. increased sweating. loss of bladder control. severe muscle stiffness.
Does promethazine cross the BBB?
Promethazine rapidly crosses the blood brain barrier and it is thought that the sedative effects are due to blockade of H1 receptors in the brain. Promethazine is not used clinically for its antipsychotic properties but in common with other phenothiazines exhibits antidopaminergic properties.
Do you need a prescription for promethazine hydrochloride?
Promethazine may also be used for other conditions as determined by your doctor . This medicine is only available with your doctor's prescription .
Why is promethazine a vesicant?
The drug is also a known vesicant that is highly caustic to the intima of blood vessels and surrounding tissue. Formulated with phenol, promethazine has a pH between 4 and 5.5.
What is the CPT code for promethazine HCl injection?
HCPCS Code for Injection, promethazine HCl, up to 50 mg J2550.
What is the brand name for promethazine hydrochloride injection?
Its other effects (such as anti-nausea, calming, pain relief) may work by affecting other natural substances (such as acetylcholine) and by acting directly on certain parts of the brain. Promethazine is available under the following different brand names: Phenergan, and Phenadoz.
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What is Approval Package for Promethazine Hydrochloride Injection?
The Approval Package for Promethazine Hydrochloride Injection is a compilation of documents and data submitted to the regulatory authority to obtain approval for the manufacturing and marketing of the drug. It includes information about the drug's formulation, manufacturing process, clinical data, and labeling.
Who is required to file Approval Package for Promethazine Hydrochloride Injection?
Pharmaceutical companies and manufacturers planning to produce and sell Promethazine Hydrochloride Injection are required to file the Approval Package with the appropriate regulatory agency.
How to fill out Approval Package for Promethazine Hydrochloride Injection?
To fill out the Approval Package, applicants must provide comprehensive details regarding the drug's formulation, pharmacology, toxicology, and clinical trial results, as well as complete any required forms and submit supporting documents as mandated by the regulatory authority.
What is the purpose of Approval Package for Promethazine Hydrochloride Injection?
The purpose of the Approval Package is to provide sufficient evidence to the regulatory authority that Promethazine Hydrochloride Injection is safe, effective, and manufactured according to regulatory standards, thereby allowing the drug to be approved for public use.
What information must be reported on Approval Package for Promethazine Hydrochloride Injection?
The Approval Package must report information including the drug's active ingredients, dosage form, manufacturing methods, quality control measures, results from clinical trials, proposed labeling, and any available safety and efficacy data.
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