Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074617
Company: ATHENEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/28/1996 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
04/03/2001 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/12/2000 SUPPL-9 Labeling

Label is not available on this site.

06/28/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/30/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/30/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/30/2000 SUPPL-4 Labeling

Label is not available on this site.

03/30/2000 SUPPL-3 Manufacturing (CMC)-New Strength

Label is not available on this site.

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

Label is not available on this site.

09/27/1996 SUPPL-1 Labeling

Label is not available on this site.

DILTIAZEM HYDROCHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075086 AKORN INC
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 074617 ATHENEX INC
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 202651 HIKMA FARMACEUTICA
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 074941 HOSPIRA
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075749 INTL MEDICATION
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 078538 WEST-WARD PHARMS INT

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