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SODIUM NITROPRUSSIDE

ANDA

SODIUM NITROPRUSSIDE | A215846 | HAINAN POLY PHARM CO LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: NIPRIDE RTU IN SODIUM CHLORIDE 0.9%

API Supply Chain14 active DMFs1 inactive

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

STERLING PHARMA USA LLCSODIUM NITROPRUSSIDE USP

DMF 274682014

ALCHYMARS ICM SM PRIVATE LTDSODIUM NITROPRUSSIDE USP

DMF 278122013

CHEMCON GMBHSODIUM NITROPRUSSIDE DIHYDRATE

DMF 281602014

MICRO LABS LTDSODIUM NITROPRUSSIDE USP

DMF 291562015

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSODIUM NITROPRUSSIDE

DMF 296472015

EMCURE PHARMACEUTICALS LTDSODIUM NITROPRUSSIDE USP

DMF 296942015

CHEMWERTH INCSODIUM NITROPRUSSIDE

DMF 297232015

AMPHASTAR NANJING PHARMACEUTICALS INCSODIUM NITROPRUSSIDE USP

DMF 298712015

MATRIX PHARMACORP PRIVATE LTDSODIUM NITROPRUSSIDE USP

DMF 308492016

NAVINTA LLCSODIUM NITROPRUSSIDE USP

DMF 311642017

SUN PHARMACEUTICAL INDUSTRIES LTDSODIUM NITROPRUSSIDE USP

DMF 312622017

APITORIA PHARMA PRIVATE LTDSODIUM NITROPRUSSIDE USP

DMF 323932017

HAINAN POLY PHARMACEUTICAL CO LTDSODIUM NITROPRUSSIDE USP

DMF 330232018

ANHUI POLY PHARM CO LTDSODIUM NITROPRUSSIDE USP

DMF 399472024

HOSPIRA BOULDER INCInactiveSODIUM NITROPRUSSIDE

DMF 46921982

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 7, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG/50ML (0.2MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Aug 26, 2022

No patent or exclusivity listings for this strength.

#002 — 20MG/100ML (0.2MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Aug 26, 2022

#003 — 50MG/100ML (0.5MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Aug 26, 2022