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BETA-2

ANDA

ISOETHARINE HYDROCHLORIDE | A086711 | NEPHRON CORP

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Teva Pharmaceutical Industries Ltd Teva Respiratory LLC FDA-2014-P-1660 · 3 docket documents Teva Pharmaceutical Industries Ltd and Teva Respiratory LLC filed a citizen petition requesting that the FDA withdraw or suspend approval of Novartis's Onbrez Breezhaler (indacaterol), a long-acting beta-2 agonist indicated for chronic obstructive pulmonary disease, based on safety concerns and alle	Other	2014-10-23	Partially Denied	Teva Pharmaceutical Industries Ltd Teva Respiratory LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

BI CHEMICALS INCInactiveISOETHARINE HYDROCHLORIDE

DMF 121161996

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

Products (1)

#001 — 1%

0 patents0 exclusivities▴

SOLUTION;INHALATION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.