Hepatitis B
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-11-06FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for BARACLUDE (entecavir) submitted by E.R. Squibb & Sons, L.L.C., resulting in updated/expanded…
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FDA approval · 2019-11-04FDA Approved: ENTECAVIR — Original Application (Yaopharma Co., Ltd.)
FDA approved Yaopharma Co., Ltd.'s entecavir as an original application (ANDA212201).
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FDA approval · 2019-09-25FDA Approved: ENTECAVIR — Original Application (EPIC PHARMA, LLC)
FDA approves EPIC PHARMA, LLC's original application for entecavir (ENTECAVIR), a generic antiviral for chronic hepatitis B infection.
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FDA approval · 2019-07-01FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's supplemental application for the generic fixed-dose combination emtricitabine and tenofovir disoproxil fumarate for the …
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FDA approval · 2019-05-31FDA Approved: ENTECAVIR — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Entacavir by Camber Pharmaceuticals, expanding the availability of a generic entecavir product. …
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FDA approval · 2019-05-13FDA Approved: ENTECAVIR — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for Entacavir (ENTECAVIR) filed by NorthStar RxLLC under ANDA 206872.
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FDA approval · 2019-05-01FDA Approved: LAMIVUDINE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's original application for lamivudine (generic). Lamivudine is used in combination therapy for…
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FDA approval · 2019-04-16FDA Approved: ENTECAVIR — Supplemental Application (AvKARE)
FDA approved a supplemental application for AvKARE to market entecavir, a hepatitis B antiviral, creating availability of a generic version.…
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FDA approval · 2019-04-04FDA Approved: ENTECAVIR — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for entecavir filed by Zydus Lifesciences Limited under an ANDA.
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FDA approval · 2019-03-21FDA Approved: LAMIVUDINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' generic lamivudine as an original generic application for HIV-1 infection and chronic hepatitis B. This…
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FDA approval · 2019-03-10FDA Approved: ENTECAVIR — Supplemental Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's supplemental application to market entecavir (ENTECAVIR) as a generic, expanding access for treatmen…
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FDA approval · 2019-02-04FDA Approved: VEMLIDY — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Vemlidy (tenofovir alafenamide) from Gilead Sciences; the action represents a regulatory update …
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FDA approval · 2018-12-20FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for BARACLUDE (entecavir) submitted by E.R. Squibb & Sons, L.L.C.
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FDA approval · 2018-12-20FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for BARACLUDE (entecavir) submitted by E.R. Squibb & Sons, L.L.C., regarding BARACLUDE.
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FDA approval · 2018-07-06FDA Approved: ADEFOVIR DIPIVOXIL — Original Application (Apotex Corp.)
FDA approved Apotex's original application (ANDA) for Adefovir Dipivoxil, a generic antiviral for chronic hepatitis B infection.
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FDA approval · 2018-07-03FDA Approved: VEMLIDY — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Vemlidy (tenofovir alafenamide) from Gilead Sciences, Inc.
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FDA approval · 2018-06-22FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for BARACLUDE (entecavir) submitted by E.R. Squibb & Sons, LLC.
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FDA approval · 2018-06-22FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA has approved a supplemental application for BARACLUDE (entecavir) by E.R. Squibb & Sons, L.L.C., indicating an update to the product…
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FDA approval · 2018-04-19FDA Approved: LAMIVUDINE — Original Application (Strides Pharma Science Limited)
FDA approved Strides Pharma Science Limited's original ANDA for lamivudine, a generic antiviral used to treat HIV-1 infection and chronic he…
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FDA approval · 2018-03-02FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Quinn Pharmaceuticals)
FDA approves an original ANDA for a generic tenofovir disoproxil fumarate from Quinn Pharmaceuticals for the treatment of HIV infection and …
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FDA approval · 2018-01-26FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's generic Tenofovir disoproxil fumarate under an Original Application for use in HIV-1 infecti…
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FDA approval · 2018-01-26FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for Tenofovir disoproxil fumarate from Aurobindo Pharma Limited, authorizing a generic version of the …
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FDA approval · 2018-01-26FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Cipla USA Inc.)
FDA approved the original generic application for tenofovir disoproxil fumarate (Cipla USA Inc.), enabling a generic version of the HIV and …
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FDA approval · 2017-10-10FDA Approved: ENTECAVIR — Original Application (Solco Healthcare LLC)
FDA approves the original generic application for entecavir, enabling Solco Healthcare LLC to market the generic antiviral for hepatitis B.
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FDA approval · 2017-06-23FDA Approved: ENTECAVIR — Original Application (Zydus Lifesciences Limited)
FDA approves the original application for ENTECAVIR (Entecavir) from Zydus Lifesciences Limited, a generic version of Baraclude for chronic …