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Registervenlafaxine study [Regulatives / Guidelines]
Dear eswar
As far as Venlafaxine ER capsule is considered (ANDA), FDA has recommended us to do only fed state single dose study with 150 mg. In addition, if your formulation can be sprinkled over soft food, then you have to carry a Sprinkle study in fed state.
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Edit: Capitals reformatted to bold. [HS]
As far as Venlafaxine ER capsule is considered (ANDA), FDA has recommended us to do only fed state single dose study with 150 mg. In addition, if your formulation can be sprinkled over soft food, then you have to carry a Sprinkle study in fed state.
--
Edit: Capitals reformatted to bold. [HS]
Complete thread:
- venlafaxine study eswar lal 2007-01-09 17:36
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- MR ANDA Jaime_R 2007-01-09 17:49
- MR ANDA drshiv 2007-02-28 18:26
- venlafaxine studyvelupharm 2007-03-01 17:00
- venlafaxine study Helmut 2007-06-01 12:45
Ing. Helmut Schütz