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TERBUTALINE SULFATE

ANDA

TERBUTALINE SULFATE | A211832 | TWI PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BRETHINE(TE code: AB)

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.

Products (2)

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#001 — 2.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 19, 2020

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 19, 2020