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BETAXOLOL HYDROCHLORIDE

ANDA

BETAXOLOL HYDROCHLORIDE | A075630 | EUROFARMA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: BETOPTIC(TE code: AT)

API Supply Chain3 active DMFs4 inactive

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

LUSOCHIMICA SPABETAXOLOL HYDROCHLORIDE

DMF 107271994

OLON SPABETAXOLOL HYDROCHLORIDE

DMF 172352004

INDOCO REMEDIES LTDBETAXOLOL HYDROCHLORIDE USP

DMF 253012011

LABORATOIRES DETUDES ET DE RECHERCHES SYNTHELABOInactiveBETAXOLOL

DMF 38001980

LABORATOIRES DETUDES ET DE RECHERCHES SYNTHELABOInactiveBETAXOLOL HYDROCHLORIDE

DMF 54641984

FINORGA SASInactiveBETAXOLOL HYDROCHLORIDE

DMF 62861986

SIFAVITOR SRLInactiveBETAXOLOL HYDROCHLORIDE

DMF 126801997

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2005	ORIG -1	View Letter (PDF)
Apr 12, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.5% BASE

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Apr 12, 2001

No patent or exclusivity listings for this strength.