Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074941
Company: HOSPIRA

Products on ANDA 074941

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074941

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-941_Diltiazem_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-941_Diltiazem_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-941_Diltiazem.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2017	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/22/2006	SUPPL-6	Labeling		Label is not available on this site.
02/14/2001	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/12/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 074941

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/15/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-941_Diltiazem_prntlbl.pdf