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Sterile Water for Inhalation: Package Insert / Prescribing Info

Package insert / product label
Dosage form: inhalation solution
Drug class: Sterile irrigating solutions

Medically reviewed by Drugs.com. Last updated on Nov 28, 2024.

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Medicinal Ingredient: Water 1 g/mL

NON PYROGENIC

pH 5

FOR INHALATION THERAPY ONLY

NOT FOR PARENTAREL ADMINISTRATION

Recommended Storage: Room temperature (25°C/77°F)

Avoid Excessive Heat. Protect from freezing.

Manufactured For:

SENSIMEDICAL LLC

19495 Biscayne Blvd PH2

Aventura, Florida 33180

Made in El Salvador

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STERILE WATER FOR INHALATION
sterile water for inhalation inhalant
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:78718-000
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1 g in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78718-000-01500 mL in 1 BAG; Type 0: Not a Combination Product04/30/2021
2NDC:78718-000-001000 mL in 1 BAG; Type 0: Not a Combination Product04/30/2021
3NDC:78718-000-022000 mL in 1 BAG; Type 0: Not a Combination Product04/30/2021
4NDC:78718-000-21250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2021
5NDC:78718-000-23500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2021
6NDC:78718-000-251000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2021
7NDC:78718-000-272000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/30/2021
Labeler - SENSIMEDICAL LLC (117526048)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Biogalenic851259507manufacture(78718-000) , api manufacture(78718-000)

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Sterile water Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 3 for sterile water.

Jynneos (Smallpox and Mpox Vaccine, Live, Non-replicating) - Bavarian Nordic A/S
Formulation type Strength
Single-Dose Vial 0.5-3.95 X 10 E8 INF. U/.5 mL
Single-Dose Vial 0.5-3.95 X 10 E8 INF. U/.5 mL
M-M-R Ii (Measles, Mumps and Rubella Virus Vaccine Live) - Merck Sharp & Dohme LLC
Formulation type Strength
Single-Dose Vial 0.5 mL
Single-Dose Vial 0.5 mL
Zostavax (Zoster Vaccine Live) - Merck Sharp & Dohme LLC
Formulation type Strength
Single-Dose Vial 0.65 mL Discontinued

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