Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074521
Company: WEST-WARD PHARMS INT
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
10/18/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/11/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/05/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/05/1997 SUPPL-4 Labeling

Label is not available on this site.

09/05/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-1 Manufacturing (CMC)

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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