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 PHOSPHATE از شرکت IMPAX LABS INC
Abbreviated New Drug Application (ANDA): 204717
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
AB |
No | No |
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 80MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/07/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204717Orig1s000TAltr.pdf |
CARVEDILOL PHOSPHATE
CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204717 | IMPAX LABS INC |
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090132 | SUN PHARM INDUSTRIES |
| COREG CR | CARVEDILOL PHOSPHATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022012 | WOODWARD |
CAPSULE, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204717 | IMPAX LABS INC |
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090132 | SUN PHARM INDUSTRIES |
| COREG CR | CARVEDILOL PHOSPHATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022012 | WOODWARD |
CAPSULE, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204717 | IMPAX LABS INC |
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090132 | SUN PHARM INDUSTRIES |
| COREG CR | CARVEDILOL PHOSPHATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022012 | WOODWARD |
CAPSULE, EXTENDED RELEASE;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204717 | IMPAX LABS INC |
| CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090132 | SUN PHARM INDUSTRIES |
| COREG CR | CARVEDILOL PHOSPHATE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022012 | WOODWARD |
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