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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

CYSTEINE HYDROCHLORIDE

ANDA

Tentative Approval

CYSTEINE HYDROCHLORIDE | A214082 | DR REDDYS LABS SA

API Supply Chain0 active DMFs1 inactive

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

NIPPON RIKAGAKUYAKUHIN CO LTDInactiveCYSTEINE HYDROCHLORIDE

DMF 107411994

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 26, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG/10ML (50MG/ML)

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SOLUTION;INTRAVENOUS | TA Date: 2023-03-01 00:00:00

No patent or exclusivity listings for this strength.