The Ingredients: Acetaminophen; Hydrocodone Bitartrate
Dosage Form and Administration: Tablet; Oral
U Drug Trade Name: Vicodin Hp
Firm: Abbott
Strength: 660MG;10MG
New Drug Application Type: A
The Drug Application Number: 40117
Medicine Product Number: 1
Approval Date: 9/23/1996
Reference Listed Drug: No
Type: RX
Applicant Full Name: Abbott Laboratories Pharmaceutical Products Div
Local Number: 19627

Behavioral Therapies

Behavioral therapies are helpful to addicts in the following ways: by motivating people to participate in drug treatment offer strategies for coping with drug cravings; teaching addicts ways to avoid drugs and prevent relapse; and helping individuals deal with relapse if it occurs. Behavioral therapies can also help people improve communication, relationships and parenting skills, as well as aid family dynamics. Many treatment programs employ both individual and group therapies. Group therapy offers social reinforcement and helps enforce behavioral contingencies that promote abstinence and a lifestyle without drugs. Some physicians employ established behavioral treatments, like contingency management and cognitive behavioral therapy, in group settings to improve efficiency and cost-effectiveness. However, particularly with adolescents with addictions, there is a danger of iatrogenic or inadvertent effects of group treatment. Because behavioral therapies address different aspects of addiction, combinations of treatments and medications may be more effective than either approach alone. Doctors administer treatments for drug abuse and addiction in many different settings through a variety of behavioral and pharmacological approaches.

Medical Device

A medical device is a product used for medical purposes in patients, in diagnosis, therapy or surgery. Medicinal products achieve their principal action by pharmacological, metabolic or immunological, medical devices act by other means like physical, mechanical, physio-chemical or chemical means. Medical devices are a part of medical technology. Medical devices include a wide range of products varying in complexity and application. The Food and Drug Administration recognizes three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the devices. Class I devices are subject to the least regulatory control. "General Controls" apply to all Class I, II and III devices. General controls include provisions that relate to adulteration; misbranding; device registration and listing; pre-market notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices. Class I devices are not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury. Most Class I devices are exempt from the pre-market notification and/or good manufacturing practices regulation. Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing rules provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. A few Class II devices are exempt from pre-market notification [10]. Special controls may include particular labeling requirements, mandatory performance standards and post-market surveillance. The FDA holds Class II medical devices to a higher level of assurance than Class I devices, as Class II devices must perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps and surgical drapes. A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Such a device needs pre-market approval, a scientific review to ensure the safety and effectiveness of the device, and is subject to all the general controls of Class I devices. The FDA classifies Class III devices as those that support or sustain human life and are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Examples of Class III devices (which currently require a pre-market notification) include implantable pacemaker pulse generators and endosseous implants.

Sensitive Skin

Sensitive skin is a thin or a fine-textured skin that reacts quickly to both heat and cold and therefore sunburns and windburns easily. It is commonly dry, delicate and prone to allergic reactions. Temperature changes, some detergents, cosmetics and alcohol (used on the skin) can all cause irritation, leaving the skin red and blotchy, with visible surface veins. The skin is the largest organ of the human body. Its size (about 20 square feet on an average sized adult) and external location make it susceptible to a wide variety of diseases, disorders, discolorations and growths, as well as to damage from the environment and the aging process.

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FDA Medical Device Registration

Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States must register annually with the FDA, which is a process known as establishment registration. Congress has authorized FDA to collect an annual establishment registration fee for device establishment registrations. A detailed list of all those establishment types that have to pay the registration fee is available at "Who Must Register, List and Pay the Fee." There are no reductions in annual establishment registration fees for small businesses or any other group. Most establishments that are required to register with the FDA are also required to list the devices made there and the functions of those devices. If a device requires pre-market approval or notification before marketed in the U.S., then the owner/operator should also submit the FDA pre-market submission number. The amendments to the Medical Device User Fee Modernization Act require that after September 30, 2007, all businesses submit registration and listing information electronically. Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. This information augments the ability of the United States to prepare for and respond to public health emergencies.