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Appendix 2 -Label differences between the pioneer, Vetmedin® 1.25 mg, 2.5 mg, 5 mg & 10 mg…

Supporting & Related Material · FDA-2023-P-2583 · posted Jun 23, 2023

Key facts

Document ID FDA-2023-P-2583-0005
Title Appendix 2 -Label differences between the pioneer, Vetmedin® 1.25 mg, 2.5 mg, 5 mg & 10 mg (pimobendan) Chewable Tablets [NADA 141-273, Boehringer Ingelheim Vetmedica, Inc.] and the proposed generic, Pimobendan 5 mg/mL Oral Suspension [Norbrook Laboratories Ltd] RE Suitability Petition from Norbrook Laboratories Limited
Document type Supporting & Related Material
Subtype Background Material
Agency FDA
Docket FDA-2023-P-2583
Posted Jun 23, 2023

At a glance

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Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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