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AMVAZ

NDA

AMLODIPINE MALEATE | N021435 | DR REDDYS LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs2 inactive

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

DR REDDYS LABORATORIES LTDInactiveAMLODIPINE MALEATE

DMF 157462001

XIAN LIBANG PHARMACEUTICAL CO LTDInactiveAMLODIPINE MALEATE AND BESYLATE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 171302004

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 28, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 31, 2003

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 31, 2003

#003 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 31, 2003