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LEVOTHYROXINE SODIUM

ANDA

LEVOTHYROXINE SODIUM | A211369 | ANI PHARMACEUTICALS INC

6 strengths0 unique patents0 unique exclusivities

API Supply Chain10 active DMFs3 inactive

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

SANDOZ GMBHLEVOTHYROXINE SODIUM

DMF 47891983

PEPTIDO GMBHLEVOTHYROXINE SODIUM

DMF 147152000

EXCELLA GMBH AND CO KGLEVOTHYROXINE SODIUM

DMF 244022011

AZICO BIOPHORE INDIA PVT LTDLEVOTHYROXINE SODIUM

DMF 290982015

GLAND PHARMA LTDLEVOTHYROXINE SODIUM USP

DMF 295502015

LUPIN LTDLEVOTHYROXINE SODIUM USP

DMF 303762016

MACLEODS PHARMACEUTICALS LTDLEVOTHYROXINE SODIUM USP

DMF 312032017

AURORE LIFE SCIENCES PRIVATE LTDLEVOTHYROXINE SODIUM USP

DMF 340442019

VALARY LAB PRIVATE LTDLEVOTHYROXINE SODIUM

DMF 381292023

SUN PHARMACEUTICAL INDUSTRIES LTDLEVOTHYROXINE SODIUM USP

DMF 427812025

RHODIA INDUSTRIE CHIMIQUE MULHOUSE DORNACHInactiveLEVOTHYROXINE SODIUM USP

DMF 142561999

APOTEX PHARMACHEM INDIA PVT LTDInactiveLEVOTHYROXINE SODIUM USP

DMF 258182012

APOTEX PHARMACHEM INDIA PVT LTDInactiveLEVOTHYROXINE SODIUM USP

DMF 301132016

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 7, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 0.075MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 28, 2020

No patent or exclusivity listings for this strength.

#002 — 0.15MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 28, 2020

#003 — 0.112MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 16, 2021

#004 — 0.2MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 9, 2022

#005 — 0.137MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 2, 2023

#006 — 0.175MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 2, 2023