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FDA Approval Activities for this Drug…
Dextroamphetamine Sulfate Extended Release Capsules USP, 5, 10 & 15mg, Mallinckrodt, ANDA 76-353 5/6/03 Dextroamphetamine Sulfate Extended Release Capsules USP, 5, 10 & 15mg, Barr laboratories, ANDA 76-137 1/18/02 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Mutual Pharmaceutical Co. ANDA 40-480 9/9/03 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Abrika ANDA 40-472 9/30/03 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Watson ANDA 40-456 5/6/03 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 10 mg, 20 mg, and 30 mg, Corepharma ANDA 40-444 6/19/02 4/9/03 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Mallinckrodt ANDA 40-440 10/7/03 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 20 mg, and 30 mg, Eon Labs, ANDA 40-439 6/14/02 4/9/03 Dextroamphetamine Sulfate Tablets USP, 5 mg & 10 mg, Mallinckrodt ANDA 40-436 1/29/02 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate & Amphetamine Sulfate Tablets, 5, 10, 20 & 30 mg, Barr, ANDA 40-422 2/11/02 Dextroamphetamine Sulfate Tablets USP, 10 mg, KV Pharmaceutical ANDA 40-367 10/31/02 Dextroamphetamine Sulfate Tablets USP, 5 mg, KV Pharmaceutical ANDA 40-365 10/31/02 Dextroamphetamine Sulfate Tablets USP, 5 mg and 10 mg. Barr, ANDA 40-361 1/31/01 06/11/02 06/11/02 06/11/02 Dextroamphetamine Sulfate Tablets USP, 5 mg. Endo Pharmaceutical ANDA 40-299 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 1.25MG;1.25MG;1.25MG;1.25MG ADDERALL XR 5 SHIRE 021303 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 2.5MG;2.5MG;2.5MG;2.5MG ADDERALL XR 10 SHIRE 021303 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 3.75MG;3.75MG;3.75MG;3.75MG ADDERALL XR 15 SHIRE 021303 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 5MG;5MG;5MG;5MG ADDERALL XR 20 SHIRE 021303 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 6.25MG;6.25MG;6.25MG;6.25MG ADDERALL XR 25 SHIRE 021303 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 7.5MG;7.5MG;7.5MG;7.5MG ADDERALL XR 30 SHIRE 040472 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Abrika 040472 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Abrika 040472 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Abrika 040472 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Abrika 040422 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Barr 040422 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 1.875MG;1.875MG;1.875MG;1.875MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Barr 040422 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Barr 040422 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 3.125MG;3.125MG;3.125MG;3.125MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Barr 040422 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 3.75MG;3.75MG;3.75MG;3.75MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Barr 040422 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Barr 040422 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Barr 040444 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Corepharma 040444 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Corepharma 040444 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Corepharma 040444 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Corepharma 040470 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Eon 040439 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Eon 040439 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Eon 040439 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Eon 040480 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Mutual 040480 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 1.875MG;1.875MG;1.875MG;1.875MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Mutual 040480 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Mutual 040480 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 3.125MG;3.125MG;3.125MG;3.125MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Mutual 040480 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 3.75MG;3.75MG;3.75MG;3.75MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Mutual 040480 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Mutual 040480 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Mutual 011522 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 1.25MG;1.25MG;1.25MG;1.25MG ADDERALL 5 SHIRE 011522 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 1.875MG;1.875MG;1.875MG;1.875MG ADDERALL 7.5 SHIRE 011522 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 2.5MG;2.5MG;2.5MG;2.5MG ADDERALL 10 SHIRE 011522 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 3.125MG;3.125MG;3.125MG;3.125MG ADDERALL 12.5 SHIRE 011522 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 3.75MG;3.75MG;3.75MG;3.75MG ADDERALL 15 SHIRE 011522 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 5MG;5MG;5MG;5MG ADDERALL 20 SHIRE 011522 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 7.5MG;7.5MG;7.5MG;7.5MG ADDERALL 30 SHIRE 040456 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Watson 040456 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Watson 040456 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Watson 040456 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Tablet; 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE Watson 076137 DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 10MG DEXTROAMPHETAMINE SULFATE Barr 076137 DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 15MG DEXTROAMPHETAMINE SULFATE Barr 076137 DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 5MG DEXTROAMPHETAMINE SULFATE Barr 017078 DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 10MG DEXEDRINE GLAXOSMITHKLINE 017078 DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 15MG DEXEDRINE GLAXOSMITHKLINE 017078 DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 5MG DEXEDRINE GLAXOSMITHKLINE 076353 DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 10MG DEXTROAMPHETAMINE SULFATE Mallinckrodt 076353 DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 15MG DEXTROAMPHETAMINE SULFATE Mallinckrodt 076353 DEXTROAMPHETAMINE SULFATE Capsule, Extended Release; 5MG DEXTROAMPHETAMINE SULFATE Mallinckrodt 040361 DEXTROAMPHETAMINE SULFATE Tablet; 10MG DEXTROAMPHETAMINE SULFATE Barr 040361 DEXTROAMPHETAMINE SULFATE Tablet; 5MG DEXTROAMPHETAMINE SULFATE Barr 040299 DEXTROAMPHETAMINE SULFATE Tablet; 5MG DEXTROAMPHETAMINE SULFATE ENDO 084935 DEXTROAMPHETAMINE SULFATE Tablet; 5MG DEXEDRINE GLAXOSMITHKLINE 040367 DEXTROAMPHETAMINE SULFATE Tablet; 10MG DEXTROAMPHETAMINE SULFATE KV 040365 DEXTROAMPHETAMINE SULFATE Tablet; 5MG DEXTROAMPHETAMINE SULFATE KV 040436 DEXTROAMPHETAMINE SULFATE Tablet; 10MG DEXTROAMPHETAMINE SULFATE Mallinckrodt | 040436 DEXTROAMPHETAMINE SULFATE Tablet; 5MG DEXTROAMPHETAMINE SULFATE Mallinckrodt | 084051 DEXTROAMPHETAMINE SULFATE Tablet; 10MG DEXTROSTAT SHIRE RICHWOOD | 084051 DEXTROAMPHETAMINE SULFATE Tablet; 5MG DEXTROSTAT SHIRE RICHWOOD | Dextroamphetamine Sulfate Extended-Release Capsules, Able Labs, Approved | Adderall XR Extended-Release Capsule, Shire Dev., Patient Population Altered | Dexedrine (dextroamphetamine sulfate) Spansule Sustained-Release Capsules and Tablets, GlaxoSmithKline, Labeling Revision | Dexedrine (dextroamphetamine sulfate) Spansule Sustained-Release Capsules, GlaxoSmithKline, Labeling Revision | Dextroamphetamine Sulfate Oral Solution, Mikart Inc., Approval | Dexedrine (dextroamphetamine sulfate) Extended-Release Capsules, GlaxoSmithKline, Labeling RevisionAdderall XR (amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate) Extended-Release Capsules, Shire Development, Inc., Labeling Revision
  
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