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Fda.gov/cder/ob/default.htm Updates to the Orange Book Daily Website and App Generic Drug approvals Patents Monthly Website App and Publication Additions NDA approvals and New exclusivities Changes active ingredient discontinued products strength dosage form route therapeutic equivalence TE code Trade name Annually Website App and Publication Annual Orange Book Edition Publication Drug Product Listing Active Ingredient Proprietary Name Dosage Form Route of Administration Strength...
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What is generic drugs and form?
Generic drugs are copies of brand-name drugs that have the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. The form is the official document required to be filled out when submitting information about the generic drug.
Who is required to file generic drugs and form?
Manufacturers or distributors of generic drugs are required to file the generic drugs and form.
How to fill out generic drugs and form?
The generic drugs and form must be filled out with all the required information about the generic drug, including its name, dosage, intended use, side effects, and safety profile.
What is the purpose of generic drugs and form?
The purpose of the generic drugs and form is to provide detailed information about generic drugs to ensure their safety, efficacy, and quality for consumers.
What information must be reported on generic drugs and form?
The generic drugs and form must include information such as the generic drug's name, dosage, intended use, side effects, risks, safety profile, and manufacturing details.
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