Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211884
Company: VISTAPHARM
Company: VISTAPHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUCRALFATE | SUCRALFATE | 1GM/10ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
03/15/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211884Orig1s000ltr.pdf |
SUCRALFATE
SUSPENSION;ORAL; 1GM/10ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARAFATE | SUCRALFATE | 1GM/10ML | SUSPENSION;ORAL | Prescription | Yes | AB | 019183 | ABBVIE |
SUCRALFATE | SUCRALFATE | 1GM/10ML | SUSPENSION;ORAL | Prescription | No | AB | 216726 | ABON PHARMS LLC |
SUCRALFATE | SUCRALFATE | 1GM/10ML | SUSPENSION;ORAL | Prescription | No | AB | 209356 | AMNEAL |
SUCRALFATE | SUCRALFATE | 1GM/10ML | SUSPENSION;ORAL | Prescription | No | AB | 212913 | MYLAN |
SUCRALFATE | SUCRALFATE | 1GM/10ML | SUSPENSION;ORAL | Prescription | No | AB | 213549 | PD PARTNERS |
SUCRALFATE | SUCRALFATE | 1GM/10ML | SUSPENSION;ORAL | Prescription | No | AB | 211884 | VISTAPHARM |