Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217134
Company: HAINAN POLY
Company: HAINAN POLY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IOPAMIDOL | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Prescription | AP2 | No | No |
IOPAMIDOL | IOPAMIDOL | 51% | INJECTABLE;INJECTION | Prescription | AP | No | No |
IOPAMIDOL | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | AP | No | No |
IOPAMIDOL | IOPAMIDOL | 76% | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
09/27/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217134Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/09/2024 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
IOPAMIDOL
INJECTABLE;INJECTION; 41%
TE Code = AP2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IOPAMIDOL | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Prescription | No | AP2 | 217134 | HAINAN POLY |
ISOVUE-200 | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Prescription | Yes | AP2 | 018735 | BRACCO |
INJECTABLE;INJECTION; 51%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IOPAMIDOL | IOPAMIDOL | 51% | INJECTABLE;INJECTION | Prescription | No | AP | 217134 | HAINAN POLY |
ISOVUE-250 | IOPAMIDOL | 51% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018735 | BRACCO |
INJECTABLE;INJECTION; 61%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IOPAMIDOL | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | No | AP | 215382 | HAINAN POLY |
IOPAMIDOL | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | No | AP | 217134 | HAINAN POLY |
ISOVUE-300 | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018735 | BRACCO |
ISOVUE-M 300 | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018735 | BRACCO |
INJECTABLE;INJECTION; 76%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IOPAMIDOL | IOPAMIDOL | 76% | INJECTABLE;INJECTION | Prescription | No | AP | 217134 | HAINAN POLY |
ISOVUE-370 | IOPAMIDOL | 76% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018735 | BRACCO |