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REMIFENTANIL HYDROCHLORIDE

ANDA

REMIFENTANIL HYDROCHLORIDE | A206223 | FRESENIUS KABI USA LLC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ULTIVA(TE code: AP)

API Supply Chain4 active DMFs

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

FINE CHEMICALS CORP PTY LTDREMIFENTANIL HYDROCHLORIDE

DMF 281062014

NAVINTA LLCREMIFENTANIL HYDROCHLORIDE

DMF 301562016

YICHANG HUMANWELL PHARMACEUTICAL CO LTDREMIFENTANIL HYDROCHLORIDE

DMF 331512018

AMPAC FINE CHEMICALS LLCREMIFENTANIL HYDROCHLORIDE

DMF 343032020

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 17, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 1MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 16, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 16, 2018

#003 — EQ 5MG BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 16, 2018