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BRETHINE

NDA

TERBUTALINE SULFATE | N017849 | ANI PHARMACEUTICALS INC

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 Chain2 active DMFs2 inactive

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

CAMBREX PROFARMACO MILANO SRLTERBUTALINE SULFATE

DMF 119271996

MELODY HEALTHCARE PVT LTDTERBUTALINE SULFATE USP

DMF 265632012

CIPLA LTDInactiveTERBUTALINE SULFATE USP

DMF 80621989

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveTERBUTALINE SULFATE

DMF 90651991

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 23, 2003	SUPPL -39	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982