Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072854
Company: AIPING PHARM INC
Company: AIPING PHARM INC
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 11/19/1991 | 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 |
|---|---|---|---|---|---|
| 05/13/2026 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/23/2015 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/03/2006 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 02/03/2006 | SUPPL-14 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 06/28/2005 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 08/27/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/21/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/05/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 02/05/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/26/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 01/24/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CYCLOBENZAPRINE HYDROCHLORIDE
TABLET;ORAL; 7.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 071611 | ACTAVIS LABS FL INC |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 072854 | AIPING PHARM INC |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 078218 | CHARTWELL RX |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 077563 | JUBILANT CADISTA |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 218936 | RISING |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 208170 | RUBICON RESEARCH |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 213324 | UNICHEM |