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
ACARBOSE از شرکت IMPAX LABS
Abbreviated New Drug Application (ANDA): 078441
Company: IMPAX LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACARBOSE | ACARBOSE | 25MG | TABLET;ORAL | Prescription |
AB |
No | No |
| ACARBOSE | ACARBOSE | 50MG | TABLET;ORAL | Prescription |
AB |
No | No |
| ACARBOSE | ACARBOSE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/14/2009 | ORIG-1 | Approval |
|
Label is not available on this site. |
ACARBOSE
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACARBOSE | ACARBOSE | 25MG | TABLET;ORAL | Prescription | No | AB | 202271 | EMCURE PHARMS LTD |
| ACARBOSE | ACARBOSE | 25MG | TABLET;ORAL | Prescription | No | AB | 078470 | HIKMA |
| ACARBOSE | ACARBOSE | 25MG | TABLET;ORAL | Prescription | No | AB | 078441 | IMPAX LABS |
| ACARBOSE | ACARBOSE | 25MG | TABLET;ORAL | Prescription | No | AB | 090912 | STRIDES PHARMA |
| ACARBOSE | ACARBOSE | 25MG | TABLET;ORAL | Prescription | No | AB | 091343 | VIRTUS PHARM |
| ACARBOSE | ACARBOSE | 25MG | TABLET;ORAL | Prescription | No | AB | 077532 | WATSON LABS |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACARBOSE | ACARBOSE | 50MG | TABLET;ORAL | Prescription | No | AB | 202271 | EMCURE PHARMS LTD |
| ACARBOSE | ACARBOSE | 50MG | TABLET;ORAL | Prescription | No | AB | 078470 | HIKMA |
| ACARBOSE | ACARBOSE | 50MG | TABLET;ORAL | Prescription | No | AB | 078441 | IMPAX LABS |
| ACARBOSE | ACARBOSE | 50MG | TABLET;ORAL | Prescription | No | AB | 090912 | STRIDES PHARMA |
| ACARBOSE | ACARBOSE | 50MG | TABLET;ORAL | Prescription | No | AB | 091343 | VIRTUS PHARM |
| ACARBOSE | ACARBOSE | 50MG | TABLET;ORAL | Prescription | No | AB | 077532 | WATSON LABS |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACARBOSE | ACARBOSE | 100MG | TABLET;ORAL | Prescription | No | AB | 202271 | EMCURE PHARMS LTD |
| ACARBOSE | ACARBOSE | 100MG | TABLET;ORAL | Prescription | No | AB | 078470 | HIKMA |
| ACARBOSE | ACARBOSE | 100MG | TABLET;ORAL | Prescription | No | AB | 078441 | IMPAX LABS |
| ACARBOSE | ACARBOSE | 100MG | TABLET;ORAL | Prescription | No | AB | 090912 | STRIDES PHARMA |
| ACARBOSE | ACARBOSE | 100MG | TABLET;ORAL | Prescription | No | AB | 091343 | VIRTUS PHARM |
| ACARBOSE | ACARBOSE | 100MG | TABLET;ORAL | Prescription | No | AB | 077532 | WATSON LABS |
منبع : www.accessdata.fda.gov
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