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LIOTHYRONINE SODIUM

ANDA

LIOTHYRONINE SODIUM | A091382 | SUN PHARMACEUTICAL INDUSTRIES LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CYTOMEL(TE code: AB)

API Supply Chain4 active DMFs1 inactive

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

PEPTIDO GMBHLIOTHYRONINE SODIUM

DMF 194672006

AZICO BIOPHORE INDIA PVT LTDLIOTHYRONINE SODIUM

DMF 309422016

VALARY LAB LTDLIOTHYRONINE SODIUM

DMF 389032023

MACLEODS PHARMACEUTICALS LTDLIOTHYRONINE SODIUM USP

DMF 424012025

SANDOZ GMBHInactiveLIOTHYRONINE SODIUM

DMF 71101987

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 22, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 0.005MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 20, 2016

No patent or exclusivity listings for this strength.

#002 — EQ 0.025MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 20, 2016

#003 — EQ 0.05MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 20, 2016