Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074956
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPYRIDAMOLE DIPYRIDAMOLE 5MG/ML 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
09/30/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74956ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74956_Dipridamole.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/05/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

02/15/2001 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/21/2000 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

DIPYRIDAMOLE

INJECTABLE;INJECTION; 5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIPYRIDAMOLE DIPYRIDAMOLE 5MG/ML INJECTABLE;INJECTION Prescription No AP 074939 ATHENEX INC
DIPYRIDAMOLE DIPYRIDAMOLE 5MG/ML INJECTABLE;INJECTION Prescription No AP 074956 FRESENIUS KABI USA
DIPYRIDAMOLE DIPYRIDAMOLE 5MG/ML INJECTABLE;INJECTION Prescription No AP 074521 WEST-WARD PHARMS INT

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