prefilled syringes fda

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prefilled syringes fda

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271/371/372 Fluzone all presentations including High-Dose – FDA

2018-2019 Formula. Initial US Approval (Fluzone …. Before administering a dose
of vaccine, shake the prefilled syringe or vial. Withdraw one dose of. 5 vaccine …

At the time of initial posting on 7/3/2018 the Labeling … – FDA

Jul 3, 2018 … for intramuscular use. 2018-2019 Formula …. Attach a sterile needle to the
prefilled syringe and administer intramuscularly. 18. The preferred …

January 10, 2018 Package Insert – Fluzone – FDA

Jan 10, 2018 … (pink plunger rod), 0.25 mL; prefilled single-dose syringe (clearplunger …. Before
administering a dose of vaccine, shake the prefilled syringe or …

Package Insert – AFLURIA QUADRIVALENT – FDA

Jun 4, 2018 … 2018-2019 Formula … 0.5 mL pre-filled syringe (single dose) (3, 11) …. When
using the single-dose pre-filled syringe, shake the syringe …

Individuals using assistive technology may not be able to fully … – FDA

Suspension for injection supplied in 0.5 mL single-dose pre-filled syringes. (3) …..
three influenza strains recommended for the 2018/2019 influenza season;.

Individuals using assistive technology may not be able to fully … – FDA

May 23, 2016 … 2018-2019 Formula. Initial U.S. Approval: …. Attach a sterile needle to the pre-
filled syringe. … a 0.5 mL single-dose pre-filled Luer Lock syringe.

Package Insert – Afluria – FDA

Jun 4, 2018 … 2018-2019 Formula … 0.5 mL pre-filled syringe (single dose) (3, 11) …. When
using the single-dose pre-filled syringe, shake the syringe …

Package Insert – Flublok Quadrivalent – FDA

Invert the pre-filled syringe containing Flublok Quadrivalent gently prior to ….. For
the 2018-2019 influenza season it is formulated to contain 180 mcg HA per 0.5 …

BLA 761080 BLA APPROVAL Hospira, Inc. Attention: Neeti … – FDA

Jul 19, 2018 … prefilled syringes and 300 mcg/1.0 mL and 480 mcg/1.6 mL single-dose vials.
LICENSING … Interim Report Submission: 01/2019. Final Report …

Summary Basis of Regulatory Action Date: May 23, 2016 … – FDA

May 23, 2016 … Dosage Forms: Suspension for injection supplied in 0.5 mL single-dose, prefilled
syringes … This preservative-free, non-adjuvanted vaccine is presented in a pre-
filled (single- ….. Final protocol submission date: June 30, 2019.

Approval Letter: BLA 125522/Original 1 – FDA

Aug 27, 2015 … single-use prefilled syringe containing 140 mg/mL evolocumab injection and as a
1 mL single- use SureClick … The dating period for Repatha 140 mg prefilled
syringe shall be 24 months from the date of …. September 2019.

BLA 761077 BLA APPROVAL Amgen, Inc. Attention: Vanessa … – FDA

May 17, 2018 … prefilled syringe 70 mg/mL and autoinjector 70 mg/mL. DATING PERIOD. The
dating … Final report submission: 09/2019. PMR 3392-2 An …

211172Orig1s000 – FDA

Oct 4, 2018 … as a single-dose, prefilled syringe (including a safety syringe device).b …… and
the (September 2009 Draft Guidance Document, 2019), Format.

BLA 761067 BLA APPROVAL Merck Sharp & Dohme … – FDA

Mar 20, 2018 … name, ILUMYA, and market it in 100 mg/1 mL single-dose prefilled syringe.
DATING PERIOD. The dating … Final Protocol Submission: 06/2019.

Trulicity (dulaglutide) – FDA

Sep 18, 2014 … finished syringes will be assembled into pre-filled pens, labeled, and packaged
at Eli … pre-filled syringes and pre-filled pens. …. June 2019.

Approval Letter: BLA 761042 – FDA

Aug 30, 2016 … Final Report Submission: December 2019. Reports of this … drug product pre-
filled syringes to generate data from commercial batches to …

oregon health authority immunization protocol for pharmacists …

Sep 19, 2018 … All influenza vaccines for use in the 2018–2019 influenza season (Northern ….
IIV4. ≥7 years. 0.5-mL single- dose prefilled syringe. None. ≤0.04 … is the only
FDA-approved influenza vaccine for use with the PharmaJet.

ACIP recommendations – CDC

Aug 23, 2018 … only one Southern Hemisphere formulation is licensed by FDA. (Fluzone …
managed by CDC and FDA. • VAERS … 0.5 mL prefilled syringe.