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LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, are at present listed within the "Discontinued Drug Product List" part of the Orange Guide.
After considering the citizen petition and reviewing Company records and primarily based on the knowledge we've presently, FDA has determined under § 314.161 that LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, were not withdrawn for reasons of security or effectiveness.
This dedication may be made at any time after the drug has been withdrawn from sale but have to be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that doesn't confer with a listed drug.
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