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SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

ANDA

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | A202388 | SANDOZ INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: JANUMET(TE code: AB)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Services Inc. - Citizen Petition FDA-2012-P-0826 · 3 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed a petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Sitagliptin and Metformin Hydrochloride Extended-release Tablets, 50 mg/850 mg suitable for consideration in an ANDA, with	Other	2012-09-06	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain0 active DMFs1 inactive

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

LIPHA SASInactiveMETFORMIN ( LA-6023),500MG.&850MG. TABLETS

DMF 59591985

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 13, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG;EQ 50MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 2, 2025

No patent or exclusivity listings for this strength.

#002 — 1GM;EQ 50MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 2, 2025