Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073144
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/31/1991 | 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 |
|---|---|---|---|---|---|
| 04/11/2013 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/22/2005 | SUPPL-15 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 07/22/2005 | SUPPL-14 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 07/22/2005 | SUPPL-13 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 07/22/2005 | SUPPL-12 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 07/22/2005 | SUPPL-11 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 02/03/2006 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 07/22/2005 | SUPPL-9 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 06/28/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/06/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/31/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/07/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/07/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 09/07/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |