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 HIKMA
Abbreviated New Drug Application (ANDA): 078470
Company: HIKMA
| 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 |
|---|---|---|---|---|---|---|---|
| 05/07/2008 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078470s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/24/2008 | SUPPL-1 | Labeling |
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 |
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