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Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API




FDA Approval Activities for this Drug…

Sonata (zaleplon) CIV Capsules, Wyeth-Ayerst NDA 20-859/S2 & S3 5/31/02 6/3/02 Sonata (zaleplon) Capsule, 5 mg & 10 mg, Wyeth-Ayerst NDA 20-859/S1 2/22/01 3/5/01 3/5/01 Sonata (zaleplon) Capsule, Wyeth-Ayerst NDA 20-859 8/13/99 3/21/00 3/21/00 7/3/00 Sonata Indications: short-term treatment of insomnia ZALEPLON Capsule; 10MG SONATA JONES 020859 ZALEPLON Capsule; 5MG SONATA JONES | Zaleplon Capsules, Roxane Labs, Tentative Approval | Zaleplon Capsules, Teva Pharma, Tentative Approval | Zaleplon Capsules, Genpharm, Tentative Approval | Sonata (zaleplon) Capsules, King Pharma, Labeling Revision | Zaleplon Capsules, Roxane Laboratories, Inc., Approval | Zaleplon Capsules, Genpharm ULC, Approval | Zaleplon Capsules, Sandoz, Inc., Approval | Zaleplon Capsules, Upsher-Smith Laboratories, Inc., Approval | Zaleplon Capsules, Aurobindo Pharma USA, Inc., Approval | Zaleplon Capsules, Unichem Pharmaceuticals USA, Inc., Approval | Zaleplon Capsules, Teva Pharmaceuticals USA, Approval | Zaleplon Capsules, Cipla, Ltd., Approval | Zaleplon Capsules, West-ward Pharmaceutical Corp., Approval | Zaleplon Capsules, Orchid Healthcare, Approval | Sonata, zaleplon, Capsule; Oral, King Pharms, Manufacturing Change or Addition | Sonata, zaleplon, Capsule; Oral, King Pharms, Labeling Revision

^ FDA's latest approval appears at the bottom of this list. ^



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