Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216941
Company: ENCUBE
Company: ENCUBE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MESALAMINE | MESALAMINE | 4GM/60ML | ENEMA;RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 05/30/2023 | 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 |
|---|---|---|---|---|---|
| 04/12/2024 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
MESALAMINE
ENEMA;RECTAL; 4GM/60ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MESALAMINE | MESALAMINE | 4GM/60ML | ENEMA;RECTAL | Prescription | No | AB | 216941 | ENCUBE |
| MESALAMINE | MESALAMINE | 4GM/60ML | ENEMA;RECTAL | Prescription | No | AB | 076751 | PADAGIS ISRAEL |
| ROWASA | MESALAMINE | 4GM/60ML | ENEMA;RECTAL | Prescription | Yes | AB | 019618 | MYLAN SPECIALITY LP |
| SFROWASA | MESALAMINE | 4GM/60ML | ENEMA;RECTAL | Prescription | Yes | AB | 019618 | MYLAN SPECIALITY LP |