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ROCURONIUM BROMIDE

ANDA

ROCURONIUM BROMIDE | A213476 | KNACK PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain14 active DMFs3 inactive

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

ASPEN OSS BVROCURONIUM BROMIDE

DMF 98541992

WAVELENGTH ENTERPRISES LTDROCURONIUM BROMIDE

DMF 195722006

FARMHISPANIA SAROCURONIUM BROMIDE USP

DMF 198192006

TAPI NL BVROCURONIUM BROMIDE

DMF 200682006

GLAND PHARMA LTDROCURONIUM BROMIDE USP

DMF 208332007

GLAND CHEMICALS PRIVATE LTDROCURONIUM BROMIDE USP

DMF 264412012

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDROCURONIUM BROMIDE USP NON-STERILE BULK DRUG SUBSTANCE

DMF 267652012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDROCURONIUM BROMIDE USP

DMF 297412015

CHENGDU SINO-STRONG PHARMACEUTICAL CO LTDROCURONIUM BROMIDE

DMF 340572019

CURIA ITALY SRLROCURONIUM BROMIDE

DMF 342522019

SHANGHAI NEUTAN PHARMACEUTICAL CO LTDROCURONIUM BROMIDE INTERMEDIATE G (NEU1017-G)

DMF 366562022

SHANGHAI JUNMED HEALTHCARE CO LTDROCURONIUM BROMIDE (NEU1017-I)

DMF 376982023

MANKIND PHARMA LTDROCURONIUM BROMIDE USP

DMF 394372024

FARMHISPANIA SAROCURONIUM BROMIDE USP-PROCESS II

DMF 418942025

DR REDDYS LABORATORIES LTDInactiveROCURONIUM BROMIDE

DMF 208612007

RELIANCE LIFE SCIENCES PVT LTDInactiveROCURONIUM BROMIDE USP

DMF 251562011

AMRI ITALY SRLInactiveROCURONIUM BROMIDE

DMF 256222011

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

Products (2)

Sort:

#001 — 50MG/5ML (10MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 6, 2026

No patent or exclusivity listings for this strength.

#002 — 100MG/10ML (10MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 6, 2026

Change History (4)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

ROCURONIUM BROMIDE (rocuronium bromide) by KNACK transitioned from prescription (RX) to discontinued (DISCN) status for NDA 213476.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

Rocuronium Bromide (KNACK) therapeutic equivalence code changed from AP to a different classification.

Old: AP

MODIFIEDTE Code7/1/2026

KNACK's rocuronium bromide (NDA 213476) therapeutic equivalence code changed from AP to a different classification.

Old: AP

MODIFIEDtype7/1/2026

ROCURONIUM BROMIDE (rocuronium bromide) application A|213476|002 by KNACK changed from prescription to discontinued status.

Old: RX

New: DISCN