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SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

ANDA

SODIUM CHLORIDE | A078177 | FRESENIUS MEDICAL CARE NORTH AMERICA

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Jubilant HollisterStier (Formerly Hollister-Stier Labor... FDA-2011-P-0846 Jubilant HollisterStier submitted this suitability petition under 21 CFR 314.93 and Section 505(j)(2)(c) requesting FDA declare that 0.9% Sodium Chloride Injection USP in various fill volumes (0.5mL, 2.5mL, 3mL, and 10mL) in vials is suitable for submission as an ANDA, with the reference listed drug	Other	2011-11-29	Withdrawn	Jubilant HollisterStier (Formerly Hollister-Stier Laboratories LLC)

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

Products (1)

#001 — 900MG/100ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 12, 2007

No patent or exclusivity listings for this strength.