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AMLODIPINE BENZOATE

ANDA

AMLODIPINE BENZOATE | A215035 | AMNEAL PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ALKEM LABORATORIES LTDAMLODIPINE BENZOATE

DMF 356102021

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 10, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1MG BASE/ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Jun 13, 2023

No patent or exclusivity listings for this strength.