Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075191
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PENTOXIFYLLINE | PENTOXIFYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | 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 |
|---|---|---|---|---|---|---|---|
| 06/09/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75191ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/29/2017 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/18/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/2001 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/18/2001 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/18/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
PENTOXIFYLLINE
TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PENTOXIFYLLINE | PENTOXIFYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 074878 | ANI PHARMS |
| PENTOXIFYLLINE | PENTOXIFYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075191 | APOTEX |
| PENTOXIFYLLINE | PENTOXIFYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075028 | VALEANT PHARMS |