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): 219084
Company: BROOKS STERISCIENCE

Products on ANDA 219084

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEROPENEM	MEROPENEM	2GM/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219084

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219084

MEROPENEM

POWDER;INTRAVENOUS; 2GM/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEROPENEM	MEROPENEM	2GM/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	219084	BROOKS STERISCIENCE
MEROPENEM	MEROPENEM	2GM/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	215212	HQ SPCLT PHARMA

Top