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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217134
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-Container/Carton Labels, Labeling-Package Insert

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
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