Drugs@FDA: FDA-Approved Drugs
Company: ACERTIS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENDIMETRAZINE TARTRATE | PHENDIMETRAZINE TARTRATE | 105MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/16/1979 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/13/2020 | SUPPL-37 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018074Orig1s037lbl.pdf | ||
| 03/22/2019 | SUPPL-36 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018074s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018074Orig1s036ltr.pdf | |
| 02/10/2012 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018074s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018074s034ltr.pdf | |
| 11/08/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1999 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 11/03/1998 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 09/23/1998 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1996 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/1995 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/17/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1985 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1982 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/10/1981 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/10/1981 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1981 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1981 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/25/1980 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/05/1981 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/18/1980 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/28/1980 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/01/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/26/1979 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/26/1979 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/15/1979 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/1979 | 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 |
|---|---|---|---|---|---|
| 11/13/2020 | SUPPL-37 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018074Orig1s037lbl.pdf | |
| 03/22/2019 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018074s036lbl.pdf | |
| 03/22/2019 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018074s036lbl.pdf | |
| 02/10/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018074s034lbl.pdf |