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
CARBAMAZEPINE از شرکت NOSTRUM LABS INC
Abbreviated New Drug Application (ANDA): 076697
Company: NOSTRUM LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CARBAMAZEPINE | CARBAMAZEPINE | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/20/2011 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/076697Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/18/2015 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
CARBAMAZEPINE
CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078986 | APOTEX INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076697 | NOSTRUM LABS INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201106 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078592 | TEVA PHARMS |
| CARBATROL | CARBAMAZEPINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020712 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078986 | APOTEX INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076697 | NOSTRUM LABS INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201106 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078592 | TEVA PHARMS |
| CARBATROL | CARBAMAZEPINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020712 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078986 | APOTEX INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076697 | NOSTRUM LABS INC |
| CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201106 | TARO |
| CARBAMAZEPINE | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078592 | TEVA PHARMS |
| CARBATROL | CARBAMAZEPINE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020712 | TAKEDA PHARMS USA |
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