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ETHAMBUTOL HYDROCHLORIDE

ANDA

ETHAMBUTOL HYDROCHLORIDE | A075095 | EPIC PHARMA LLC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MYAMBUTOL(TE code: AB)

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
Nov 30, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 30, 1999

No patent or exclusivity listings for this strength.

#002 — 400MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 30, 1999