Viewing data from:

ZOLPIDEM TARTRATE

NDA

ZOLPIDEM TARTRATE | N215721 | ALMATICA PHARMA INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain20 active DMFs14 inactive

19 active API suppliers hold Drug Master Files for this ingredient.

HOLIDAY LABS MEXICO SA DE CVZOLPIDEM TARTRATE

DMF 151312000

FARMAK ASZOLPIDEM TARTRATE

DMF 154862001

TAPI NL BVZOLPIDEM TARTRATE

DMF 159582002

CAMBREX PROFARMACO MILANO SRLZOLPIDEM TARTRATE

DMF 170982003

SUN PHARMACEUTICAL INDUSTRIES LTDZOLPIDEM TARTRATE USP

DMF 177122004

ALIVUS LIFE SCIENCES LTDZOLPIDEM TARTRATE USP

DMF 181642005

MATRIX PHARMACORP PRIVATE LTDZOLPIDEM TARTRATE USP

DMF 182212005

LUPIN LTDZOLPIDEM TARTRATE USP

DMF 184302005

DR REDDYS LABORATORIES LTDZOLPIDEM TARTRATE

DMF 188642005

APITORIA PHARMA PRIVATE LTDZOLPIDEM TARTRATE USP

DMF 189742005

WOCKHARDT LTDZOLPIDEM TARTRATE

DMF 192892006

AARTI DRUGS LTDZOLPIDEM TARTRATE

DMF 194402006

ORCHID PHARMA LTDZOLPIDEM TARTRATE

DMF 198122006

SANOFI WINTHROP INDUSTRIEZOLPIDEM TARTRATE

DMF 209842007

UNICHEM LABORATORIES LTDZOLPIDEM TARTRATE USP

DMF 211932007

CENTAUR PHARMACEUTICALS PRIVATE LTDZOLPIDEM TARTRATE USP

DMF 307812016

ALIVUS LIFE SCIENCES LTDZOLPIDEM TARTRATE USP

DMF 318942017

YUNG ZIP CHEMICAL IND CO LTDZOLPIDEM TARTRATE

DMF 322522018

LUNAN BETTER PHARMACEUTICAL CO LTDZOLPIDEM TARTRATE USP

DMF 364722021

TORRENT PHARMACEUTICALS LTDZOLPIDEM TARTRATE USP

DMF 379982023

LABORATOIRES DETUDES ET DE RECHERCHES SYNTHELABOInactiveZOLPIDEM TARTRATE

DMF 66221986

SYNTHELABO BPInactiveZOLPIDEM TARTRATE

DMF 91591991

FINORGA SASInactiveZOLPIDEM TARTRATE MODIFIED SYNTHESIS

DMF 117641995

QUIMICA SINTETICA SAInactiveZOLPIDEM TARTRATE

DMF 158402002

ZENTIVA KSInactiveZOLPIDEM TARTRATE

DMF 166242003

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveZOLPIDEM TARTRATE

DMF 169402003

CIPLA LTDInactiveZOLPIDEM TARTRATE BP/PH.EUR.

DMF 178112004

SHANDONG LUNAN BETTER PHARMACEUTICAL CO LTDInactiveZOLPIDEM TARTRATE (NON-STERILE BULK FORM)

DMF 186972005

DIVIS LABORATORIES LTDInactiveZOLPIDEM TARTRATE USP

DMF 188082005

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveZOLPIDEM TARTRATE

DMF 189822005

CADILA PHARMACEUTICALS LTDInactiveZOLPIDEM TARTRATE

DMF 189862005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveZOLPIDEM TARTRATE DRUG SUBSTANCE

DMF 190362005

CADILA HEALTHCARE LTDInactiveZOLPIDEM TARTRATE

DMF 192242006

SYNTHON BVInactiveZOLPIDEM TARTRATE

DMF 226682009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 11, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 7.5MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 9, 2023

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

MODIFIEDTE Code7/1/2026

Zolpidem Tartrate (ALMATICA, NDA 215721) received an AB therapeutic equivalence rating, indicating bioequivalence to the reference product.

New: AB