Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204717
Company: IMPAX LABS INC
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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204717Orig1s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/24/2025 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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 | WAYLIS THERAP |
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 | WAYLIS THERAP |
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 | WAYLIS THERAP |
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 | WAYLIS THERAP |