Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216967
Company: ALEMBIC
Company: ALEMBIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MESALAMINE | MESALAMINE | 375MG | 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 |
---|---|---|---|---|---|---|---|
10/28/2022 | 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 |
---|---|---|---|---|---|
03/19/2024 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
MESALAMINE
CAPSULE, EXTENDED RELEASE;ORAL; 375MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
APRISO | MESALAMINE | 375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022301 | SALIX |
MESALAMINE | MESALAMINE | 375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216967 | ALEMBIC |
MESALAMINE | MESALAMINE | 375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214242 | ALKEM LABS LTD |
MESALAMINE | MESALAMINE | 375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217533 | AMTA |
MESALAMINE | MESALAMINE | 375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214477 | AUROBINDO PHARMA LTD |
MESALAMINE | MESALAMINE | 375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207271 | MYLAN |
MESALAMINE | MESALAMINE | 375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 218410 | NOVAST LABS |
MESALAMINE | MESALAMINE | 375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208954 | ZYDUS PHARMS |