Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040453
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 1MG/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
06/09/2003 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/040453.pdf

DIHYDROERGOTAMINE MESYLATE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
D.H.E. 45 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 005929 BAUSCH
DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 206621 HIKMA PHARMS
DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 040475 PADDOCK LLC
DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 207264 SAGENT PHARMS INC
DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 040453 WEST-WARD PHARMS INT

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