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SOTALOL HYDROCHLORIDE

ANDA

SOTALOL HYDROCHLORIDE | A075429 | TEVA PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BETAPACE(TE code: AB)

API Supply Chain2 active DMFs5 inactive

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

SIEGFRIED LTDSOTALOL HYDROCHLORIDE

DMF 37211980

NEULAND LABORATORIES LTDSOTALOL HYDROCHLORIDE USP

DMF 149512000

IROTEC LABORATORIESInactiveSOTALOL HYDROCHLORIDE

DMF 118871996

ERREGIERRE SPAInactiveSOTALOL HYDROCHLORIDE

DMF 130831998

HEUMANN PHARMA GMBHInactiveSOTALOL HYDROCHLORIDE

DMF 131861998

SIFAVITOR SRLInactiveSOTALOL HYDROCHLORIDE

DMF 148412000

AREVIPHARMA GMBHInactiveSOTALOL HYDROCHLORIDE

DMF 237522010

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 17, 2004	ORIG -1	View Letter (PDF)
May 1, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 80MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 1, 2000

No patent or exclusivity listings for this strength.

#002 — 120MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 1, 2000

#003 — 160MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 1, 2000

#004 — 240MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 1, 2000