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Industry Trade Show
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02-03 March, 2026
Industry Trade Show
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14-17 February, 2026
Suppliers Night ExpoSuppliers Night Expo
Industry Trade Show
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16-17 February, 2026
Digital content

11 Feb 2026
// BIOSPACE
https://www.biospace.com/business/gilead-to-stay-proactive-and-disciplined-with-deals-but-m-a-not-urgent-priority

11 Feb 2026
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/despite-tempered-sales-outlook-gilead-positions-yeztugo-dominate-hiv-prep-market-sales-surge

10 Feb 2026
// BUSINESSWIRE
https://www.businesswire.com/news/home/20260210935221/en/Gilead-Sciences-Announces-Fourth-Quarter-and-Full-Year-2025-Financial-Results

10 Feb 2026
// BUSINESSWIRE
https://www.businesswire.com/news/home/20260210388877/en/Gilead-Sciences-Announces-3.8-Percent-Increase-in-First-Quarter-2026-Dividend

06 Feb 2026
// BUSINESSWIRE
https://www.businesswire.com/news/home/20260205203420/en/FDA-Approves-Label-Update-for-Kites-Yescarta-for-RelapsedRefractory-Primary-Central-Nervous-System-Lymphoma

06 Feb 2026
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/fierce-pharma-regulatory-tracker-2026
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9564
Submission : 1992-03-06
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25188
Submission : 2011-10-24
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25187
Submission : 2011-10-21
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 229MF10061
Registrant's Address : 1021 Hayter Road Edmonton, Alberta T6S 1A1, Canada
Initial Date of Registration : 2017-03-07
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 227MF10232
Registrant's Address : 1021 Hayter Road Edmonton, Alberta T6S 1A1, Canada
Initial Date of Registration : 2015-09-24
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12688
Submission : 1997-10-07
Status : Inactive
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16237
Submission : 2002-11-06
Status : Inactive
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10967
Submission : 1994-06-15
Status : Inactive
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15661
Submission : 2001-10-12
Status : Inactive
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16033
Submission : 2002-06-28
Status : Inactive
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9517
Submission : 1992-01-31
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6805
Submission : 1987-01-28
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7680
Submission : 1988-09-23
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8724
Submission : 1990-09-07
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9564
Submission : 1992-03-06
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25188
Submission : 2011-10-24
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9024
Submission : 1991-03-13
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25187
Submission : 2011-10-21
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16237
Submission : 2002-11-06
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12688
Submission : 1997-10-07
Status : Inactive
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : HEPSERA
Dosage Strength : 10MG **Federal Register ...
Approval Date : 2002-09-20
Application Number : 21449
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : LETAIRIS
Dosage Strength : 5MG
Approval Date : 2007-06-15
Application Number : 22081
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB

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RLD : Yes
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : LETAIRIS
Dosage Strength : 10MG
Approval Date : 2007-06-15
Application Number : 22081
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB

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RLD : Yes
TE Code :
Dosage Form : FOR SOLUTION; INHALATION
Proprietary Name : CAYSTON
Dosage Strength : 75MG/VIAL
Approval Date : 2010-02-22
Application Number : 50814
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Dosage Form : TABLET; ORAL
Proprietary Name : BIKTARVY
Dosage Strength : EQ 50MG BASE;200MG;EQ 25...
Approval Date : 2018-02-07
Application Number : 210251
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Dosage Form : TABLET; ORAL
Proprietary Name : BIKTARVY
Dosage Strength : EQ 30MG BASE;120MG;EQ 15...
Approval Date : 2021-10-07
Application Number : 210251
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : VISTIDE
Dosage Strength : EQ 375MG BASE/5ML (EQ 75...
Approval Date : 1996-06-26
Application Number : 20638
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : TYBOST
Dosage Strength : 150MG
Approval Date : 2014-09-24
Application Number : 203094
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : TYBOST
Dosage Strength : 90MG
Approval Date : 2025-06-20
Application Number : 203094
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Dosage Form : TABLET; ORAL
Proprietary Name : GENVOYA
Dosage Strength : 150MG;150MG;200MG;EQ 10M...
Approval Date : 2015-11-05
Application Number : 207561
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

Excipients
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
Gilead Sciences is a supplier offers 21 products (APIs, Excipients or Intermediates).
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