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AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE

ANDA

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE | A217490 | ALKEM LABORATORIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: EDARBYCLOR(TE code: AB)

API Supply Chain4 active DMFs

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

LINHAI TIANYU PHARMACEUTICAL CO LTDAZILSARTAN

DMF 396542024

REYOUNG CORPORATIONAZILSARTAN

DMF 397532024

JIANGXI SYNERGY PHARMACEUTICAL CO LTDAZILSARTAN

DMF 404332024

WUHAN RS PHARMACEUTICALS CO LTDAZILSARTAN

DMF 406452024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 24, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 40MG MEDOXOMIL;12.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 21, 2025

No patent or exclusivity listings for this strength.

#002 — EQ 40MG MEDOXOMIL;25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 21, 2025