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FDA Guidance for Generic Asthma Drugs

FDA Guidance for Industry Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate Active ingredient: Fluticasone Propionate; Salmeterol Xinafoate Form/Route: Powder/Inhalation Recommended...

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FDA ANDA Submissions-Content and Format

Guidance for Industry ANDA Submissions-Content and Format of Abbreviated New Drug Applications This guidance is intended to assist applicants in preparing abbreviated new drug applications (more…)

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ANDA Submissions – Refuse-to-Receive Standards

Guidance for Industry By Global Compliance Seminar (LinkedIn; Twitter) ANDA Submissions – Refuse-to-Receive Standards May 2015 Generic Drugs Revision 1 This guidance is intended to assist applicants...

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Questions and Answers for ANDAs Stability Testing

FDA Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers May 2014 This guidance provides answers to questions from the public (more…)

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ANDA Submissions-Content and Format

Guidance for Industry By Global Compliance Seminar (LinkedIn; Twitter) ANDA Submissions-Content and Format of Abbreviated New Drug Applications June 2014 Generics This guidance is intended to assist...

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