FdaApplication
NDA 011522
Identifiers
- fda_app_no: NDA011522
Properties
| Property | Value |
|---|---|
| applicant_name | TEVA WOMENS HEALTH INC |
| application_type | NDA |
| approval_date | 1996-02-13 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ADDERALL 10 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ADDERALL 12.5 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ADDERALL 15 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ADDERALL 20 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ADDERALL 30 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ADDERALL 5 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ADDERALL 7.5 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
7 products