An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207594
Company: HQ SPCLT PHARMA

Products on ANDA 207594

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMIPENEM AND CILASTATIN	CILASTATIN SODIUM; IMIPENEM	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207594

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207594

IMIPENEM AND CILASTATIN

POWDER;INTRAVENOUS; EQ 500MG BASE/VIAL;500MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMIPENEM AND CILASTATIN	CILASTATIN SODIUM; IMIPENEM	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	090577	ACS DOBFAR
IMIPENEM AND CILASTATIN	CILASTATIN SODIUM; IMIPENEM	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	207594	HQ SPCLT PHARMA
PRIMAXIN	CILASTATIN SODIUM; IMIPENEM	EQ 500MG BASE/VIAL;500MG/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	050587	MERCK

Top