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CHLOROPROCAINE HYDROCHLORIDE

ANDA

CHLOROPROCAINE HYDROCHLORIDE | A040273 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: NESACAINE(TE code: AP)

API Supply Chain3 active DMFs1 inactive

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

SIEGFRIED EVIONNAZ SACHLOROPROCAINE HYDROCHLORIDE

DMF 80021989

EDMOND PHARMA SRLCHLOROPROCAINE HYDROCHLORIDE

DMF 356982021

SHANGHAI WONDER PHARMACEUTICAL CO LTDCHLOROPROCAINE HYDROCHLORIDE

DMF 392682023

WUHAN WUYAO PHARMACEUTICAL CO LTDInactiveCHLOROPROCAINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)

DMF 231472009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 9, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 2%

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 9, 1998

No patent or exclusivity listings for this strength.

#002 — 3%

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 9, 1998