Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204043
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 02/28/2017 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/13/2024 | SUPPL-16 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/03/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/03/2024 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/11/2021 | SUPPL-11 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/21/2021 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/15/2021 | SUPPL-8 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/03/2024 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/27/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/27/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/27/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CELLCEPT | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050758 | ROCHE PALO |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214283 | BPI LABS |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212130 | MEITHEAL |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203859 | MYLAN LABS LTD |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216390 | ONESOURCE SPECIALTY |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203575 | PH HEALTH |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204043 | RISING |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204473 | ZYDUS PHARMS |