Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074431
Company: NEW HEIGHTSRX
Company: NEW HEIGHTSRX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLURBIPROFEN | FLURBIPROFEN | 100MG | TABLET;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/31/1995 | 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 |
|---|---|---|---|---|---|
| 11/29/2010 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2006 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/13/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/27/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |