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SOTALOL HYDROCHLORIDE

ANDA

SOTALOL HYDROCHLORIDE | A075515 | SUN PHARMACEUTICAL INDUSTRIES INC

4 strengths0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Apr 14, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 80MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 15, 2001

No patent or exclusivity listings for this strength.

#002 — 160MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 15, 2001

#003 — 240MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 15, 2001

#004 — 120MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 15, 2001