Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215721
Company: ALMATICA

• Medication Guide

Products on NDA 215721

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	7.5MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215721

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2023	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215721s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215721Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/215721Orig1s000TOC.html

Labels for NDA 215721

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/09/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215721s000lbl.pdf

Therapeutic Equivalents for NDA 215721

ZOLPIDEM TARTRATE

CAPSULE;ORAL; 7.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	7.5MG	CAPSULE;ORAL	Prescription	Yes	AB	215721	ALMATICA
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	7.5MG	CAPSULE;ORAL	Prescription	No	AB	220717	UMEDICA LABS PVT