Viewing data from:

DARTISLA ODT

NDA

GLYCOPYRROLATE | N215019 | EDENBRIDGE PHARMACEUTICALS LLC

2 strengths0 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 Chain16 active DMFs7 inactive

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

AMSA SPAGLYCOPYRROLATE

DMF 169722003

PCASGLYCOPYRROLATE

DMF 181062005

HIKMA PHARMACEUTICALS LLCGLYCOPYRROLATE USP

DMF 187272005

AKSHAT PHARMA PRIVATE LTDGLYCOPYRROLATE USP

DMF 190262005

HARMAN FINOCHEM LTDGLYCOPYRROLATE USP

DMF 197102006

TAI HENG INDUSTRY CO LTDGLYCOPYRROLATE USP

DMF 213262008

RESONANCE LABORATORIES PVT LTDGLYCOPYRROLATE

DMF 264702012

COHANCE LIFESCIENCES LTDGLYCOPYRROLATE USP

DMF 300612015

INKE SAGLYCOPYRROLATE

DMF 318362017

NISHCHEM INTERNATIONAL PRIVATE LTDGLYCOPYRROLATE USP

DMF 338062019

HARMAN FINOCHEM LTDGLYCOPYRROLATE TOSYLATE

DMF 341112019

HAINAN POLY PHARM CO LTDGLYCOPYRROLATE

DMF 354462021

MELODY HEALTHCARE PVT LTDGLYCOPYRROLATE USP

DMF 376482022

SWATI SPENTOSE PRIVATE LTDGLYCOPYRROLATE USP

DMF 385502023

VIYASH LIFE SCIENCES PRIVATE LTDGLYCOPYRROLATE

DMF 393372024

CIPLA LTDGLYCOPYRROLATE USP

DMF 423312025

SB PENICK AND COInactiveGLYCOPYRROLATE

DMF 4301961

BOEHRINGER INGELHEIM CHEMICALS INCInactiveGLYCOPYRROLATE

DMF 60441985

BOCA PHARMACAL LLCInactiveGLYCOPYRROLATE USP

DMF 205782007

BIOFIRST PHARMACEUTICALS LLCInactiveGLYCOPYRROLATE

DMF 206882007

AUROBINDO PHARMA LTDInactiveGLYCOPYRROLATE USP, NON-STERILE DRUG SUBSTANCE

DMF 207662007

CERBIOS PHARMA SAInactiveGLYCOPYRROLATE USP

DMF 293312017

HOVIONE PHARMASCIENCE LTDInactiveGLYCOPYRROLATE INHALATION GRADE

DMF 312062016

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 21, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1.7MG

RLD

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Dec 16, 2021

No patent or exclusivity listings for this strength.

#002 — 0.85MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 11, 2023