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ATROVENT

NDA

IPRATROPIUM BROMIDE | N020394 | BOEHRINGER INGELHEIM PHARMACEUTICALS 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 Chain7 active DMFs2 inactive

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

OLON SPAIPRATROPIUM BROMIDE

DMF 89731991

LUSOCHIMICA SPAIPRATROPIUM BROMIDE

DMF 89791991

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGIPRATROPIUM BROMIDE MONOHYDRATE

DMF 142591999

NEULAND LABORATORIES LTDIPRATROPIUM BROMIDE USP

DMF 151302000

AARTI PHARMALABS LTDIPRATROPIUM BROMIDE

DMF 211792007

AMPHASTAR NANJING PHARMACEUTICALS INCIPRATROPIUM BROMIDE USP

DMF 310362017

SCL LIFESCIENCES LTDIPRATROPIUM BROMIDE USP

DMF 379412025

DERIVADOS QUIMICOS SA FINE CHEMICALSInactiveIPRATROPIUM BROMIDE

DMF 231352009

CIPLA LTDInactiveIPRATROPIUM BROMIDE USP

DMF 298432015

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Oct 20, 1995

No patent or exclusivity listings for this strength.