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GUANABENZ ACETATE

ANDA

GUANABENZ ACETATE | A074517 | CHARTWELL RX SCIENCES LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain0 active DMFs6 inactive

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

EVONIK TECHNOCHEMIE GMBHInactiveGUANABENZ ACETATE

DMF 57391985

HELSINN CHEMICALS SAInactiveGUANABENZ ACETATE

DMF 58971985

PROSINTEX INDUSTRIE CHIMIQUE ITALIANE SRLInactiveGUANABENZ ACETATE

DMF 78421988

CILAG CHEMIE AGInactiveGUANABENZ ACETATE

DMF 79571989

FINE CHEMICALS CORPInactiveGUANABENZ ACETATE

DMF 81871989

MEDICHEM SAInactiveGUANABENZ ACETATE

DMF 82911989

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 30, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 4MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 30, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 8MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 30, 1998