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SODIUM CHLORIDE 14.6%

ANDA

SODIUM CHLORIDE | A212070 | FRESENIUS KABI USA LLC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SODIUM CHLORIDE 14.6%

API Supply Chain5 active DMFs4 inactive

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

MARIAGER SALT SPECIALTIES A/SSODIUM CHLORIDE

DMF 221912010

NANDU CHEMICALS PVT LTDSODIUM CHLORIDE BP (PARENTERAL GRADE)

DMF 231052009

NANDU CHEMICALS PVT LTDSODIUM CHLORIDE USP

DMF 284732014

VM CHEMICALSSODIUM CHLORIDE BP

DMF 290372015

EMNAR PHARMA PRIVATE LTDSODIUM CHLORIDE

DMF 414192025

CAMBRIDGE NUCLEAR RADIOPHARM CORPInactiveSODIUM CHLORIDE NA-24

DMF 22861974

ARES SERONO SAInactiveSODIUM CHLORIDE FOR INJECTION

DMF 100301993

LUITPOLD PHARMACEUTICALS INCInactiveSODIUM CHLORIDE INJECTION 0.9% 4ML FILL IN A 5ML VIAL

DMF 156592001

LUITPOLD PHARMACEUTICALS INCInactiveSODIUM CHLORIDE INJECTION USP 0.9%

DMF 215442008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 6, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MEQ/20ML (2.5MEQ/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Apr 28, 2021

No patent or exclusivity listings for this strength.

#002 — 100MEQ/40ML (2.5MEQ/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Apr 28, 2021

#003 — 400MEQ/100ML (4MEQ/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 14, 2022