Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215576
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUCRALFATE | SUCRALFATE | 1GM | TABLET;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 |
---|---|---|---|---|---|---|---|
04/15/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SUCRALFATE
TABLET;ORAL; 1GM
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARAFATE | SUCRALFATE | 1GM | TABLET;ORAL | Prescription | Yes | AB | 018333 | ABBVIE |
SUCRALFATE | SUCRALFATE | 1GM | TABLET;ORAL | Prescription | No | AB | 215576 | AMNEAL PHARMS |
SUCRALFATE | SUCRALFATE | 1GM | TABLET;ORAL | Prescription | No | AB | 074415 | NOSTRUM LABS INC |
SUCRALFATE | SUCRALFATE | 1GM | TABLET;ORAL | Prescription | No | AB | 070848 | TEVA |
SUCRALFATE | SUCRALFATE | 1GM | TABLET;ORAL | Prescription | No | AB | 215705 | ZYDUS LIFESCIENCES |