Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215012
Company: CHENGDU
Company: CHENGDU
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 01/25/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/04/2025 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
TACROLIMUS
CAPSULE, EXTENDED RELEASE;ORAL; EQ 0.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ASTAGRAF XL | TACROLIMUS | EQ 0.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204096 | ASTELLAS |
| TACROLIMUS | TACROLIMUS | EQ 0.5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215012 | CHENGDU |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 1MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ASTAGRAF XL | TACROLIMUS | EQ 1MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204096 | ASTELLAS |
| TACROLIMUS | TACROLIMUS | EQ 1MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215012 | CHENGDU |
CAPSULE, EXTENDED RELEASE;ORAL; EQ 5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ASTAGRAF XL | TACROLIMUS | EQ 5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204096 | ASTELLAS |
| TACROLIMUS | TACROLIMUS | EQ 5MG BASE | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215012 | CHENGDU |