Details for New Drug Application (NDA): 011522
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The generic ingredient in ADDERALL 7.5 is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.
Summary for 011522
Tradename: | ADDERALL 7.5 |
Applicant: | Teva Womens |
Ingredient: | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate |
Patents: | 0 |
Profile for product number 007
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 13, 1996 | TE: | RLD: | Yes |
Profile for product number 008
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 13, 1996 | TE: | RLD: | Yes |
Profile for product number 009
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 12, 1997 | TE: | RLD: | Yes |
Expired US Patents for NDA 011522
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Womens | ADDERALL 7.5 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | TABLET;ORAL | 011522-011 | Aug 31, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Womens | ADDERALL 15 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | TABLET;ORAL | 011522-013 | Aug 31, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Womens | ADDERALL 20 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | TABLET;ORAL | 011522-008 | Feb 13, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
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