Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077883
Company: APOTEX INC
Company: APOTEX INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BALSALAZIDE DISODIUM | BALSALAZIDE DISODIUM | 750MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
12/28/2007 | 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 |
---|---|---|---|---|---|
02/16/2024 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
07/30/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
07/30/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
02/05/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
06/08/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
BALSALAZIDE DISODIUM
CAPSULE;ORAL; 750MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BALSALAZIDE DISODIUM | BALSALAZIDE DISODIUM | 750MG | CAPSULE;ORAL | Prescription | No | AB | 077883 | APOTEX INC |
BALSALAZIDE DISODIUM | BALSALAZIDE DISODIUM | 750MG | CAPSULE;ORAL | Prescription | No | AB | 077806 | HIKMA |
BALSALAZIDE DISODIUM | BALSALAZIDE DISODIUM | 750MG | CAPSULE;ORAL | Prescription | No | AB | 217592 | ZYDUS LIFESCIENCES |
COLAZAL | BALSALAZIDE DISODIUM | 750MG | CAPSULE;ORAL | Prescription | Yes | AB | 020610 | VALEANT PHARMS INTL |