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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075086
Company: RISING

Products on ANDA 075086

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075086

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/09/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75086_Diltiazem%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75086_Diltiazem%20Hydrochloride_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75086_Diltiazem.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2006	SUPPL-9	Labeling		Label is not available on this site.
07/17/2006	SUPPL-2	Labeling		Label is not available on this site.
06/09/1998	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 075086

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75086_Diltiazem%20Hydrochloride_prntlbl.pdf

Therapeutic Equivalents for ANDA 075086

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	216552	EUGIA PHARMA
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078538	HIKMA
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074941	HOSPIRA
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075086	RISING
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074617	SAGENT

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