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FDA Approval Activities for this Drug…
ADDERALL (Mixed Salts of a Single-Entity Amphetamine Product) Tablets, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg Tablets. Shire Pharmaceutical Development NDA 11-522/S-030 11/8/02 11/19/02 10/9/03 ADDERALL CII (Mixed Salts of a Single-Entity Amphetamine Product) Tablets, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg, Shire Pharmaceutical Development NDA 11-522/S-029 4/11/02 Adderall XR Capsule, Shire NDA 21-303/S1 5/22/02 5/29/02 5/23/02 Adderall XR Capsule, Shire NDA 21-303 Adderall XR (mixed salts of a single-entity amphetamine product) Extended-Release Capsules, Shire, Patient Population Altered | Adderal (Mixed Salts of a Single-Entity Amphetamine) Tablets, Shire Dev., Labeling Revision | Adderall XR Capsules, Shire Dev., Labeling Revision | Adderall Tablets, Shire Dev., Labeling Revision | Adderall XR , Shire Dev., Labeling Revision
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