Drugs@FDA: FDA-Approved Drugs
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PENTOXIFYLLINE | PENTOXIFYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
07/08/1997 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/02/2020 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
01/21/2016 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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01/21/2016 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
12/12/2005 | SUPPL-14 | Labeling |
Label is not available on this site. |
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01/12/2007 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/21/2004 | SUPPL-11 | Labeling |
Label is not available on this site. |
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04/19/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/15/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/03/1999 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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11/03/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
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11/03/1999 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/22/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/25/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
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04/07/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/07/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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02/26/1998 | SUPPL-1 | Manufacturing (CMC) |
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 | 074425 | RISING |
PENTOXIFYLLINE | PENTOXIFYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075028 | VALEANT PHARMS |