Viewing data from:

ETHAMBUTOL HYDROCHLORIDE

ANDA

ETHAMBUTOL HYDROCHLORIDE | A076057 | BARR LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain2 active DMFs2 inactive

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

CADILA PHARMACEUTICALS LTDETHAMBUTOL HYDROCHLORIDE USP

DMF 111711994

LUPIN LTDETHAMBUTOL HYDROCHLORIDE USP

DMF 204042007

CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTDInactiveETHAMBUTOL HYDROCHLORIDE

DMF 63821986

CADILA PHARMACEUTICALS LTDInactiveETHAMBUTOL HYDROCHLORIDE USP SPECIAL

DMF 164662003

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 16, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 400MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 26, 2001

No patent or exclusivity listings for this strength.