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
CARVEDILOL از شرکت AUROBINDO PHARMA
Abbreviated New Drug Application (ANDA): 078332
Company: AUROBINDO PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CARVEDILOL | CARVEDILOL | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/05/2007 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078332s000_ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/03/2020 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/04/2016 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2014 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/21/2014 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/14/2013 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/19/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |
CARVEDILOL
TABLET;ORAL; 3.125MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 078332 | AUROBINDO PHARMA |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 078384 | BEXIMCO USA |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 077474 | CHARTWELL MOLECULAR |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 076649 | DR REDDYS LABS LTD |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 078251 | GLENMARK GENERICS |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 078217 | LUPIN |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 077316 | MYLAN |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 078165 | RUBICON |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 078227 | SANDOZ |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 076989 | SUN PHARM INDS LTD |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 077780 | TARO |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 076373 | TEVA |
| CARVEDILOL | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | No | AB | 077614 | ZYDUS PHARMS USA INC |
| COREG | CARVEDILOL | 3.125MG | TABLET;ORAL | Prescription | Yes | AB | 020297 | WOODWARD |
TABLET;ORAL; 6.25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 078332 | AUROBINDO PHARMA |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 078384 | BEXIMCO USA |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 077474 | CHARTWELL MOLECULAR |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 076649 | DR REDDYS LABS LTD |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 078251 | GLENMARK GENERICS |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 078217 | LUPIN |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 077316 | MYLAN |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 078165 | RUBICON |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 078227 | SANDOZ |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 076989 | SUN PHARM INDS LTD |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 077780 | TARO |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 076373 | TEVA |
| CARVEDILOL | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | No | AB | 077614 | ZYDUS PHARMS USA INC |
| COREG | CARVEDILOL | 6.25MG | TABLET;ORAL | Prescription | Yes | AB | 020297 | WOODWARD |
TABLET;ORAL; 12.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 078332 | AUROBINDO PHARMA |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 078384 | BEXIMCO USA |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 077474 | CHARTWELL MOLECULAR |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 076649 | DR REDDYS LABS LTD |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 078251 | GLENMARK GENERICS |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 078217 | LUPIN |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 077316 | MYLAN |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 078165 | RUBICON |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 078227 | SANDOZ |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 076989 | SUN PHARM INDS LTD |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 077780 | TARO |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 076373 | TEVA |
| CARVEDILOL | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | No | AB | 077614 | ZYDUS PHARMS USA INC |
| COREG | CARVEDILOL | 12.5MG | TABLET;ORAL | Prescription | Yes | AB | 020297 | WOODWARD |
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 078332 | AUROBINDO PHARMA |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 078384 | BEXIMCO USA |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 077474 | CHARTWELL MOLECULAR |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 076649 | DR REDDYS LABS LTD |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 078251 | GLENMARK GENERICS |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 078217 | LUPIN |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 077316 | MYLAN |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 078165 | RUBICON |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 078227 | SANDOZ |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 076989 | SUN PHARM INDS LTD |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 077780 | TARO |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 076373 | TEVA |
| CARVEDILOL | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | No | AB | 077614 | ZYDUS PHARMS USA INC |
| COREG | CARVEDILOL | 25MG | TABLET;ORAL | Prescription | Yes | AB | 020297 | WOODWARD |
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