Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083900
Company: SMITH KLINE & FRENCH
Company: SMITH KLINE & FRENCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENZEDRINE | AMPHETAMINE SULFATE | 5MG | Tablet; Oral | Discontinued | None | No | No |
| BENZEDRINE | AMPHETAMINE SULFATE | 10MG | Tablet; Oral | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/26/1976 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083900_amphetamine-sulfate_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/11/1981 | SUPPL-9 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S9.pdf | |
| 12/14/1979 | SUPPL-8 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S8.pdf | |
| 05/11/1982 | SUPPL-7 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S7.pdf |
| 02/06/1979 | SUPPL-6 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S6.pdf | |
| 02/11/1981 | SUPPL-5 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S5.pdf | |
| 11/21/1978 | SUPPL-4 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S4.pdf | |
| 11/21/1978 | SUPPL-3 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S3.pdf | |
| 05/11/1977 | SUPPL-2 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S2.pdf | |
| 04/15/1976 | SUPPL-1 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/83900-S1.pdf |