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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215212
Company: HQ SPCLT PHARMA

Products on NDA 215212

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEROPENEM	MEROPENEM	2GM/VIAL	POWDER;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215212

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/2023	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215212s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215212Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/215212Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2024	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215212s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215212Orig1s002ltr.pdf

Labels for NDA 215212

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215212s002lbl.pdf
07/26/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215212s000lbl.pdf

Therapeutic Equivalents for NDA 215212

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

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