اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CYCLOBENZAPRINE HYDROCHLORIDE از شرکت TWI PHARMS INC
Abbreviated New Drug Application (ANDA): 091281
Company: TWI PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, 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 |
|---|---|---|---|---|---|---|---|
| 01/31/2013 | 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 |
|---|---|---|---|---|---|
| 03/13/2018 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/06/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
CYCLOBENZAPRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMRIX | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021777 | TEVA PHARMS INTL |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206703 | APOTEX |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091281 | TWI PHARMS INC |
CAPSULE, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMRIX | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021777 | TEVA PHARMS INTL |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206703 | APOTEX |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091281 | TWI PHARMS INC |
منبع : www.accessdata.fda.gov
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