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TERBUTALINE SULFATE

ANDA

TERBUTALINE SULFATE | A076770 | CHARTWELL INJECTABLES LLC

1 strength0 unique patents0 unique exclusivities

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
Apr 29, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 23, 2004

No patent or exclusivity listings for this strength.