Exzolt ® (fluralaner oral solution)
- Manufacturer
- Merck Sharp & Dohme Corp.
- Effective date
- 2026-08-25
- Label type
- PRESCRIPTION ANIMAL DRUG LABEL
- Version
- 11
- Source
- daily-update
- Hydrated at
- 2026-09-08 02:01:02
Label at a glance#
ProductExzolt
Active ingredientFLURALANER
Label structure26 sections
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/reportanimalae
www.fda.gov/reportanimalaeLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
10 mg of fluralaner/mL
For oral administration via drinking water
PRECAUTIONS SECTION
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION SECTION
Description: Exzolt (fluralaner oral solution) is a concentrate for oral administration via drinking water containing fluralaner. Each mL of Exzolt contains 10 mg of fluralaner.
The chemical name of fluralaner is (±)-4-[5-(3,5-dichlorophenyl)-5-(trifluoromethyl)-4,5 dihydroisoxazol-3-yl]-2-methyl-N-[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl] benzamide.
INDICATIONS & USAGE SECTION
Indications for Use: Exzolt is indicated for the treatment and control of northern fowl mites (Ornithonyssus sylviarum) in laying hens, replacement chickens, and breeder chickens.
DOSAGE & ADMINISTRATION SECTION
Dosage and Administration: Exzolt must be administered orally to chickens via the drinking water as 2 single doses spaced 7 days apart, with each dose consumed over a period of 6 to 24 hours. Each dose is 0.5 mg fluralaner/kg (0.227 mg/lb) body weight, equivalent to 0.05 mL of Exzolt/kg body weight (0.023 mL/lb).
DESCRIPTION SECTION
Active Ingredient: fluralaner
SPL UNCLASSIFIED SECTION
General Mixing Directions: Determine the time period over which to administer the medicated water on the treatment day. This period of time must be a minimum of 6 hours and maximum of 24 hours and long enough to allow all birds to receive the required dose. If the medicated water will contact rusty surfaces, it must be consumed within 8 hours of preparation. Estimate how much water birds will usually consume during the selected treatment period based on the previous day's water consumption. (This volume is referred to below as "Volume of Medicated Water to be Consumed".) Ensure that the amount of medicated drinking water offered will be consumed completely within the selected treatment period (between 6 and 24 hours). No other source of drinking water should be available during the medication period. Immediately prior to treatment, remove any other source of water so that only medicated water is available to chickens during the treatment period.
Calculate the volume of Exzolt needed based on the total weight of all birds to be treated. To ensure administration of the correct dose, body weight should be estimated as accurately as possible.
The required amount of Exzolt on each treatment day is calculated from the total body weight of the entire group of chickens to be treated:
Volume of Exzolt (mL) per treatment day = Total body weight (kg) of birds to be treated × 0.05 mL/kg
Or
Volume of Exzolt (mL) per treatment day = Total body weight (lb) of birds to be treated × 0.023 mL/lb
Examples:
| Total body weight of birds to be treated | Volume of Exzolt per treatment day |
|---|---|
| 1 kg (2.2 lb) | 0.05 mL |
| 5 kg (11 lb) | 0.25 mL |
| 10 kg (22 lb) | 0.5 mL |
| 15 kg (33 lb) | 0.75 mL |
| 20 kg (44 lb) | 1 mL |
Use the provided dosing syringe for withdrawing the required volume of Exzolt from the amber glass bottle and mix with the necessary volume of drinking water as described in the following steps.
For each day of treatment, medicated water must be freshly prepared.
To prepare the medicated water, the instructions below need to be followed in the order described:
- Measure the predetermined volume of water to be medicated and consumed into a clean water dispenser, prior to measuring the medication.
- At time of initial use, remove the original cap from the bottle and discard it.
- Twist on the in-use cap provided in the carton box. Doing so will permanently insert the bottle adaptor into the neck of the bottle.
- To dose: Remove the in-use cap. Attach the 1-mL dosing syringe to the bottle by gently pushing the end of the syringe into the bottle adapter.
- Turn the bottle/syringe upside down. Pull down on the plunger to withdraw the correct dose volume. If any air bubbles are seen in the syringe, push them out and pull down again on the plunger until the correct volume is withdrawn.
- Turn the bottle/syringe upright. Remove the syringe from the syringe adaptor. Replace the in-use cap. The bottle adapter should remain in the neck of the bottle for the duration of use.
- Add the Exzolt in the syringe to a volume of fresh drinking water equivalent to the Volume of Medicated Water to be Consumed and mix. Rinse the 1-mL dosing syringe and add the rinse water to the medicated water. Provide the medicated water to the birds and ensure that all medicated water is consumed within the established treatment time period (i.e. 6 to 24 hours) before re-introducing fresh, non-medicated water.
- Clean and dry the syringe after use. The syringe may be reused for future dose administrations.
To ensure long-term control of the mite populations in a treated flock it is essential to treat any other infested poultry in proximity to the treated flock.
Warnings
SPL UNCLASSIFIED SECTION
WITHDRAWAL PERIODS: Chickens must not be slaughtered for human consumption for 11 days after the last treatment. No egg discard is required when used according to the labeling.
SPL UNCLASSIFIED SECTION
User Safety Warnings: Not for use in humans. Keep this and all drugs out of the reach of children. Protective gloves should be used. Care should be taken when handling the product to avoid skin and eye exposure, exposure of mucous membranes, and accidental ingestion. Accidental exposure may cause skin and eye irritation. In case of eye contact, immediately rinse thoroughly with water. If wearing contact lenses, immediately rinse the eyes first, then remove contact lenses and continue to rinse the eyes thoroughly. Seek medical advice if symptoms occur. Wash hands and contacted skin with soap and water after use of the product. Remove contaminated clothes and launder with detergent.
Accidental ingestion may cause gastrointestinal disturbances and hypersensitivity reactions in humans.
To obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, call Merck Animal Health at 1-800-211-3573.
SPL UNCLASSIFIED SECTION
Contact Information: Contact Merck Animal Health at 1-800-521-5767 or sp-uspoultrycustomerserviceusa@merck.com. To report suspected adverse drug experiences, contact Livestock Technical Service at 1-800-211-3573. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.
Clinical Pharmacology
MECHANISM OF ACTION SECTION
Mechanism of Action: Fluralaner is for systemic use and belongs to the class of isoxazoline-substituted benzamide derivatives. Fluralaner acts as an inhibitor of the arthropod nervous system by antagonizing ligand-gated chloride channels (gamma-aminobutyric acid [GABA]-receptor and glutamate-receptor).
PHARMACOKINETICS SECTION
Pharmacokinetics: The pharmacokinetics of fluralaner were determined in fifty-five healthy laying hens treated with two single oral administrations of Exzolt (0.5 mg/kg twice) at 7-day intervals via drinking water. Concentrations of fluralaner peaked at 36 hours after the first administration and at 12 hours after the second administration. The maximum concentration (Cmax) of fluralaner was higher after the second dose (355 ng/mL) compared to after the first dose (323 ng/mL) suggesting slight accumulation. In a subsequent study, the oral bioavailability of fluralaner was determined in chickens after intravenous and oral administration (gavage) at a dose of 0.5 mg/kg. The oral bioavailability of fluralaner is 91%.
Target Animal Safety
Two margin of safety studies (growing broiler chickens and laying hens during peak egg production) and two reproductive safety studies (layer and broiler breeder chickens) were conducted.
The margin of safety study in broiler chickens was conducted in 320 3-week-old parent stock broiler chickens (Ross 308) at 1×, 3×, or 5× the recommended dose of 0.5 mg/kg body weight for 3 times the recommended duration at 7-day intervals, and the margin of safety study in laying hens was conducted in 120 commercial laying hens (Novogen) at 1×, 3×, or 5× the label dose for 3 consecutive days each, 7 days apart. No clinically relevant effects related to the administration of Exzolt were observed.
The reproductive safety study in layer chicken breeders was conducted in 432 (48 male and 384 female) commercial Bovans strain layer breeder chickens at 3 times the recommended dose on 4 occasions, 7 days apart and the reproductive safety study in broiler chicken breeders was conducted in 432 (48 male and 384 female) commercial Cobb 500 broiler breeder chickens at 3× the recommended dose on 4 occasions, 7 days apart. No clinically relevant effects on reproductive safety parameters related to the administration of Exzolt were observed.
These studies support the safety of Exzolt in laying hens, replacement chickens, and breeder chickens when administered in drinking water as 2 single doses of 0.5 mg/kg body weight, 7 days apart.
Effectiveness
In a well-controlled dose confirmation study conducted in 128 commercial 14-week-old White Leghorn female replacement chickens (Hy-Line® strain), effectiveness against Ornithonyssus sylviarum was 100% on Days 8, 14, 19, and 28 after the first treatment. No treatment-related adverse events were observed.
In a well-controlled dose confirmation study conducted in 128 commercial 29-week-old Brown Leghorn laying hens (Hy-Line strain), effectiveness against Ornithonyssus sylviarum was 100% on Days 8 and 14 after the first treatment. No treatment-related adverse events were observed.
In a well-controlled field effectiveness study conducted in 800 commercial 23-week-old White Leghorn laying hens (Hy-Line strain), effectiveness against Ornithonyssus sylviarum exceeded 99.9% on Days 8, 14, 19, and 28 after the first treatment. No treatment-related adverse events were observed.
In a well-controlled field effectiveness study conducted in 800 commercial 28-week-old White Leghorn (Hy-Line strain) laying hens, effectiveness against Ornithonyssus sylviarum exceeded 99.9% on Days 8, 14, 19, and 28 after the first treatment. No treatment-related adverse events were observed.
In a well-controlled field effectiveness study conducted in 840 commercial 25-week-old broiler breeder chickens (Ross 708 hens and Hubbard M99 roosters), effectiveness against Ornithonyssus sylviarum was 100% on Days 8, 14, 18, 19, and 28 after the first treatment. No treatment-related adverse events were observed.
In all 5 effectiveness studies Exzolt achieved 99.3% or greater reduction in Ornithonyssus sylviarum mite counts on Day 2 following the first dose administration.
HOW SUPPLIED SECTION
How Supplied: Exzolt is available in a 4-mL amber glass container.
STORAGE AND HANDLING SECTION
Storage and Handling: Store Exzolt at or below 86°F (30°C). After first opening, store vial upright and use within 12 months. Use the medicated water within 24 hours of preparation. Use within 8 hours of preparation if the medicated water comes in contact with rusty surfaces.
SPL UNCLASSIFIED SECTION
Approved by FDA under NADA # 141-607
Distributed By: Intervet Inc. (d/b/a Merck Animal Health), 126 E. Lincoln Avenue, Rahway, NJ 07065
Copyright © 2026 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
Revision Date 08/2026
253901 R2
SPL UNCLASSIFIED SECTION
Exzolt® (fluralaner oral solution)
10 mg of fluralaner/mL
PRECAUTIONS SECTION
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION SECTION
Description: Exzolt (fluralaner oral solution) is a concentrate for oral administration via drinking water containing fluralaner. Each mL of Exzolt contains 10 mg of fluralaner.
The chemical name of fluralaner is (±)-4-[5-(3,5-dichlorophenyl)-5-(trifluoromethyl)-4,5 dihydroisoxazol-3-yl]-2-methyl-N-[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl] benzamide.
INDICATIONS & USAGE SECTION
Indications for Use: Exzolt is indicated for the treatment and control of northern fowl mites (Ornithonyssus sylviarum) in laying hens, replacement chickens, and breeder chickens.
DOSAGE & ADMINISTRATION SECTION
Dosage and Administration: Exzolt must be administered orally to chickens via the drinking water as 2 single doses spaced 7 days apart, with each dose consumed over a period of 6 to 24 hours. Each dose is 0.5 mg fluralaner/kg (0.227 mg/lb) body weight, equivalent to 0.05 mL of Exzolt/kg body weight (0.023 mL/lb).
SPL UNCLASSIFIED SECTION
General Mixing Directions: Determine the time period over which to administer the medicated water on the treatment day. This period of time must be a minimum of 6 hours and maximum of 24 hours and long enough to allow all birds to receive the required dose. If the medicated water will contact rusty surfaces, it must be consumed within 8 hours of preparation. Estimate how much water birds will usually consume during the selected treatment period based on the previous day's water consumption. Ensure that the amount of medicated drinking water offered will be consumed completely within the selected treatment period (between 6 and 24 hours). No other source of drinking water should be available during the medication period.
Calculate the volume of Exzolt needed based on the total weight of all birds in the house to be treated. To ensure administration of the correct dose, body weight should be estimated as accurately as possible and an accurate device should be used for measuring the calculated volume of product to be administered.
The required amount of Exzolt on each treatment day is calculated from the total body weight of the entire group of chickens to be treated:
Volume of Exzolt (mL) per treatment day = Total body weight (kg) of birds to be treated × 0.05 mL/kg
Or
Volume of Exzolt (mL) per treatment day = Total body weight (lb) of birds to be treated × 0.023 mL/lb
Examples:
| Total body weight of birds to be treated | Volume of Exzolt per treatment day |
|---|---|
| 5000 kg (11,023 lb) | 0.25 L (250 mL) |
| 10,000 kg (22,046 lb) | 0.5 L (500 mL) |
| 15,000 kg (33,069 lb) | 0.75 L (750 mL) |
| 20,000 kg (44,092 lb) | 1 L (1,000 mL) |
To prepare the medicated water, the instructions below need to be followed in the order described:
- Check the water system to ensure it works properly and is free of leaks; also ensure that water is available to all nipple or bell drinkers.
- For each day of treatment, medicated water must be freshly prepared.
- Mix the required volume of the product into a large medication tank or create a stock solution in a small container. The stock solution must be further diluted with drinking water and administered over time, using a proportioner or dosing pump. Always add product and water simultaneously in order to avoid foaming. It is important to rinse the measuring device used to measure the required product volume during the filling phase in order to ensure that the complete dose is emptied into the medication tank or the stock solution and that no residues remain in the measuring device.
- Stir the stock solution or the content of the medication tank gently until the medicated water is homogeneous. Connect the medication tank or the proportioner or dosing pump to the drinking water system.
- Make sure the dosing pump is properly set to deliver the medicated water during the predetermined treatment period (hours).
- Prior to introducing the medicated water, drain the drinker lines fully by opening the flush valve and checking end-line nipples to ensure no water remains.
- Prime the drinker lines with medicated water and confirm the medicated water has reached all end-line nipples.
Once the stock solution container is empty, rinse both the container and downstream water lines with unmedicated water (rinse water). Allow birds to consume the rinse water before reintroducing non-medicated water.
The full course of therapy (2 single doses 7 days apart) must be administered for full therapeutic effect.
Strict biosecurity measures at house and farm level should be implemented to prevent reinfestation of treated houses. To ensure long-term control of the mite populations in a treated house, it is essential to treat any other infested poultry in houses in proximity to the treated one.
Warnings
SPL UNCLASSIFIED SECTION
WITHDRAWAL PERIODS: Chickens must not be slaughtered for human consumption for 11 days after the last treatment. No egg discard is required when used according to the labeling.
SPL UNCLASSIFIED SECTION
User Safety Warnings: Not for use in humans. Keep this and all drugs out of the reach of children.
Protective gloves should be used. Care should be taken when handling the product to avoid skin and eye exposure, exposure of mucous membranes, and accidental ingestion. Accidental exposure may cause skin and eye irritation. In case of eye contact, immediately rinse thoroughly with water. If wearing contact lenses, immediately rinse the eyes first, then remove contact lenses and continue to rinse the eyes thoroughly. Seek medical advice if symptoms occur. Wash hands and contacted skin with soap and water after use of the product. Remove contaminated clothes and launder with detergent.
Accidental ingestion may cause gastrointestinal disturbances and hypersensitivity reactions in humans.
To obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, call Merck Animal Health at 1-800-211-3573.
SPL UNCLASSIFIED SECTION
Contact Information: Contact Merck Animal Health at 1-800-521-5767 or sp-uspoultrycustomerserviceusa@merck.com. To report suspected adverse drug experiences, contact Livestock Technical Service at 1-800-211-3573. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.
Clinical Pharmacology
MECHANISM OF ACTION SECTION
Mechanism of Action: Fluralaner is for systemic use and belongs to the class of isoxazoline-substituted benzamide derivatives. Fluralaner acts as an inhibitor of the arthropod nervous system by antagonizing ligand-gated chloride channels (gamma-aminobutyric acid [GABA]-receptor and glutamate-receptor).
PHARMACOKINETICS SECTION
Pharmacokinetics: The pharmacokinetics of fluralaner were determined in fifty-five healthy laying hens treated with two single oral administrations of Exzolt (0.5 mg/kg twice) at 7-day intervals via drinking water. Concentrations of fluralaner peaked at 36 hours after the first administration and at 12 hours after the second administration. The maximum concentration (Cmax) of fluralaner was higher after the second dose (355 ng/mL) compared to after the first dose (323 ng/mL) suggesting slight accumulation. In a subsequent study, the oral bioavailability of fluralaner was determined in chickens after intravenous and oral administration (gavage) at a dose of 0.5 mg/kg. The oral bioavailability of fluralaner is 91%.
Target Animal Safety
Two margin of safety studies (growing broiler chickens and laying hens during peak egg production) and two reproductive safety studies (layer and broiler breeder chickens) were conducted.
The margin of safety study in broiler chickens was conducted in 320 3-week-old parent stock broiler chickens (Ross 308) at 1×, 3×, or 5× the recommended dose of 0.5 mg/kg body weight for 3 times the recommended duration at 7-day intervals, and the margin of safety study in laying hens was conducted in 120 commercial laying hens (Novogen) at 1×, 3×, or 5× the label dose for 3 consecutive days each, 7 days apart. No clinically relevant effects related to the administration of Exzolt were observed.
The reproductive safety study in layer chicken breeders was conducted in 432 (48 male and 384 female) commercial Bovans strain layer breeder chickens at 3 times the recommended dose on 4 occasions, 7 days apart and the reproductive safety study in broiler chicken breeders was conducted in 432 (48 male and 384 female) commercial Cobb 500 broiler breeder chickens at 3X the recommended dose on 4 occasions, 7 days apart. No clinically relevant effects on reproductive safety parameters related to the administration of Exzolt were observed.
These studies support the safety of Exzolt in laying hens, replacement chickens, and breeder chickens when administered in drinking water as 2 single doses of 0.5 mg/kg body weight, 7 days apart.
Effectiveness
In a well-controlled dose confirmation study conducted in 128 commercial 14-week-old White Leghorn female replacement chickens (Hy-Line® strain), effectiveness against Ornithonyssus sylviarum was 100% on Days 8, 14, 19, and 28 after the first treatment. No treatment-related adverse events were observed.
In a well-controlled dose confirmation study conducted in 128 commercial 29-week-old Brown Leghorn laying hens (Hy-Line strain), effectiveness against Ornithonyssus sylviarum was 100% on Days 8 and 14 after the first treatment. No treatment-related adverse events were observed.
In a well-controlled field effectiveness study conducted in 800 commercial 23-week-old White Leghorn laying hens (Hy-Line strain), effectiveness against Ornithonyssus sylviarum exceeded 99.9% on Days 8, 14, 19, and 28 after the first treatment. No treatment-related adverse events were observed.
In a well-controlled field effectiveness study conducted in 800 commercial 28-week-old White Leghorn (Hy-Line strain) laying hens, effectiveness against Ornithonyssus sylviarum exceeded 99.9% on Days 8, 14, 19, and 28 after the first treatment. No treatment-related adverse events were observed.
In a well-controlled field effectiveness study conducted in 840 commercial 25-week-old broiler breeder chickens (Ross 708 hens and Hubbard M99 roosters), effectiveness against Ornithonyssus sylviarum was 100% on Days 8, 14, 18, 19, and 28 after the first treatment. No treatment-related adverse events were observed.
In all 5 effectiveness studies Exzolt achieved 99.3% or greater reduction in Ornithonyssus sylviarum mite counts on Day 2 following the first dose administration.
HOW SUPPLIED SECTION
How Supplied: Exzolt is available in 1- and 4-liter HDPE plastic containers.
STORAGE AND HANDLING SECTION
Storage and Handling: Store Exzolt at or below 86°F (30°C) and use within 12 months after first opening. Use the medicated water within 24 hours of preparation. Use within 8 hours of preparation if the medicated water comes in contact with rusty surfaces.
SPL UNCLASSIFIED SECTION
Approved by FDA under NADA # 141-607
Distributed By: Intervet Inc. (d/b/a Merck Animal Health), 126 E. Lincoln Avenue, Rahway, NJ 07065
Copyright © 2026 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
Revision Date 08/2026
PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
Exzolt®
(fluralaner oral solution)
1L
Before using this drug, read package insert for full prescribing
information.
Dosage and Administration: Exzolt® must be administered orally to
chickens via the drinking water as 2 single doses spaced 7 days apart,
with each dose consumed over a period of 6 to 24 hours. Each dose is
0.5 mg fluralaner/kg (0.227 mg/lb) body weight, equivalent to 0.05 mL of
Exzolt/kg body weight (0.023 mL/lb).
Active Ingredient: fluralaner
Storage and Handling: Store Exzolt at or below 86°F (30°C) and
use within 12 months after first opening. Use the medicated water
within 24 hours of preparation. Use within 8 hours of preparation if the
medicated water comes in contact with rusty surfaces.
User Safety Warnings: Not for use in humans. Keep this and all drugs
out of the reach of children.
To obtain a copy of the Safety Data Sheet (SDS) or for technical
assistance, call Merck Animal Health at 1-800-211-3573.
Mixing Directions: Read package insert for full mixing directions.
Made in: See imprint
Distributed by: Intervet Inc. (d/b/a Merck Animal Health), Rahway,
NJ 07065
Revision Date 08/2026
MERCK
Animal Health
255679 R1
PRINCIPAL DISPLAY PANEL - 4 L Bottle Label
Exzolt®
(fluralaner oral solution)
4L
Before using this drug, read package insert for
full prescribing information.
Dosage and Administration: Exzolt® must be
administered orally to chickens via the drinking
water as 2 single doses spaced 7 days apart,
with each dose consumed over a period of
6 to 24 hours. Each dose is 0.5 mg fluralaner/kg
(0.227 mg/lb) body weight, equivalent to 0.05 mL
of Exzolt/kg body weight (0.023 mL/lb).
Active Ingredient: fluralaner
Storage and Handling: Store Exzolt at or below
86°F (30°C) and use within 12 months after
first opening. Use the medicated water within
24 hours of preparation. Use within 8 hours of
preparation if the medicated water comes in
contact with rusty surfaces.
User Safety Warnings: Not for use in humans.
Keep this and all drugs out of the reach of children.
To obtain a copy of the Safety Data Sheet (SDS)
or for technical assistance, call Merck Animal
Health at 1-800-211-3573.
Mixing Directions: Read package insert for full
mixing directions.
Made in: See imprint
Distributed by: Intervet Inc. (d/b/a Merck Animal
Health), Rahway, NJ 07065
Revision Date 08/2026
MERCK
Animal Health
255681 R1
PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton
Exzolt®
(fluralaner oral solution)
10 mg of fluralaner/mL
For oral administration via drinking
water of laying hens, replacement
chickens, and breeder chickens.
Caution: Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
Net Contents: 4 mL
Approved by FDA under
NADA # 141-607
MERCK
Animal Health
Products#
Every source-derived product name is available through these pages.
- Exzolt
- fluralaner
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0061-1440 | 0061-1440-01, 0061-1440-02, 0061-1440-03 |
| 0061-1441 | 0061-1441-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FLURALANER | WSH8393RM5 | ACTIB |
| FLURALANER | WSH8393RM5 | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 10 | 2026-08-13 | daily-update | 2026-08-20 01:00:56 |
| 8 | 2026-04-22 | daily-update | 2026-06-11 05:10:14 |
| 6 | 2026-04-22 | full-release | 2026-06-01 02:46:58 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.