Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 015034
Company: AVION PHARMS
Company: AVION PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PONSTEL | MEFENAMIC ACID | 250MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/1967 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 12/31/2025 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/015034s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/015034Orig1s047ltr.pdf | |
| 11/21/2024 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/015034s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/015034Orig1s046ltr.pdf | |
| 04/28/2021 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/015034s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/015034Orig1s045ltr.pdf | |
| 05/09/2016 | SUPPL-44 | Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015034s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/015034Orig1s044ltr.pdf | |
| 01/05/2015 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/2009 | SUPPL-41 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/06/2008 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015034s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015034s040ltr.pdf | |
| 01/18/2006 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/015034s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/015034s039ltr.pdf | |
| 07/31/2001 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/2001 | SUPPL-34 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/015034_S034_PONSTEL.pdf |
| 09/01/1998 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1998 | SUPPL-32 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/015034_S032_PONSTEL.pdf |
| 04/05/1996 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1993 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-27 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/29/1984 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/1984 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/19/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1983 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/26/1982 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/1981 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1981 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1981 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/17/1981 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/17/1981 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1977 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/27/1977 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/28/1975 | SUPPL-8 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/31/2025 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/015034s047lbl.pdf | |
| 11/21/2024 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/015034s046lbl.pdf | |
| 04/28/2021 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/015034s045lbl.pdf | |
| 05/09/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015034s044lbl.pdf | |
| 05/09/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015034s044lbl.pdf | |
| 05/09/2016 | SUPPL-44 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/015034s044lbl.pdf | |
| 03/06/2008 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015034s040lbl.pdf | |
| 01/18/2006 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/015034s039lbl.pdf |
PONSTEL
CAPSULE;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MEFENAMIC ACID | MEFENAMIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 091608 | AJENAT PHARMS |
| MEFENAMIC ACID | MEFENAMIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 091322 | LUPIN LTD |
| MEFENAMIC ACID | MEFENAMIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 090562 | MICRO LABS |
| PONSTEL | MEFENAMIC ACID | 250MG | CAPSULE;ORAL | Prescription | Yes | AB | 015034 | AVION PHARMS |