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INDOMETHACIN SODIUM

ANDA

INDOMETHACIN SODIUM | A078713 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

SOLARA ACTIVE PHARMA SCIENCES LTDINDOMETHACIN SODIUM

DMF 227512009

GLAND PHARMA LTDINDOMETHACIN SODIUM USP

DMF 254012011

GLAND PHARMA LTDINDOMETHACIN SODIUM USP

DMF 272822013

FIS FABBRICA ITALIANA SINTETICI SPAINDOMETHACIN SODIUM

DMF 294412015

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 18, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 16, 2008

No patent or exclusivity listings for this strength.