Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040276
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | 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 |
---|---|---|---|---|---|---|---|
11/25/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40276_Phentermine%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40276ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040276_phentermine_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/31/2017 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
11/04/2015 | SUPPL-15 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
11/02/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/04/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/25/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40276_Phentermine%20Hydrochloride_Prntlbl.pdf |