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Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original clindamycin phosphate gel generic, and patent infringement litigation.

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  • Pharmaceutically equivalent topical products that raise questions of bioequivalence, including all post non-solution topical drug products, are coded AB when supported by adequate bioequivalence data, and BT in the absence of such data
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  • Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other

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Drug Status. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. AB Products meeting necessary bioequivalence requirements. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation.

Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Pharmaceutically equivalent topical products that raise questions clindamycin phosphate gel generic bioequivalence, including all post non-solution topical drug products, are coded AB when supported by adequate bioequivalence data, and BT in the absence of such data. There are a variety of topical dosage forms available for dermatologic, ophthalmic, otic, rectal, and vaginal administration, including creams, gels, lotions, oils, ointments, pastes, solutions, sprays and suppositories.

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Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading.


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