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    Company profile for Towa Pharmaceutical

    Towa Pharmaceutical-PSE
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    Notice of Partial Revision of Basic Policy for the Development

    17 Mar 2025

    // PRESS RELEASE

    Acquired approval for manufacture & marketing generic drugs

    17 Feb 2025

    // PRESS RELEASE

    financial results for Q3 of the year ending March 31, 202

    13 Feb 2025

    // PRESS RELEASE

    DATA COMPILATION
    #PharmaFlow

    Towa Pharmaceutical

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    Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

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    Towa being a pharmaceutical company specialized in generic drugs, has been dedicated to research and development, production, and marketing of generic drugs for many years. Generic drugs have increasingly played a very important role in this aged society, because they are economically affordable for patients and help to curtail the financial burden of the government. In addition to promoting stable supply, quality assurance, and information provision about generic drugs, Towa focuses on research and development of value-added formulations that are easily taken by patients and handled by medical professionals.

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    Towa Pharmaceuticaljapan Flag
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    Japan
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    2-11, Shinbashi-cho, Kadoma, Osaka 571-8580
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    +81 0669009100
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    enquiries@pharmacompass.com
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    https://www.towayakuhin.co.jp/english/
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    CORPORATE CONTENT #SupplierSpotlight

    Corporate Presentation

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    GMP Certificate 2023

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    DATA COMPILATION #PharmaFlow

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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    21 Nov 2024
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    NEWS #PharmaBuzz

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    Notice of Partial Revision of Basic Policy for the Development
    Notice of Partial Revision of Basic Policy for the Development

    17 Mar 2025

    // PRESS RELEASE

    https://www.towayakuhin.co.jp/english/

    PRESS RELEASE
    17 Mar 2025
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    Acquired approval for manufacture & marketing generic drugs
    Acquired approval for manufacture & marketing generic drugs

    17 Feb 2025

    // PRESS RELEASE

    https://www.towayakuhin.co.jp/english/assets/release250217.pdf

    PRESS RELEASE
    17 Feb 2025
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    financial results for Q3 of the year ending March 31, 202
    financial results for Q3 of the year ending March 31, 202

    13 Feb 2025

    // PRESS RELEASE

    https://www.towayakuhin.co.jp/english/assets/slide69c.pdf

    PRESS RELEASE
    13 Feb 2025
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    Dividend Forecasts for the Fiscal Year Ending March 31, 2025
    Dividend Forecasts for the Fiscal Year Ending March 31, 2025

    13 Feb 2025

    // PRESS RELEASE

    https://www.towayakuhin.co.jp/english/assets/release250213.pdf

    PRESS RELEASE
    13 Feb 2025
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    Consolidated Financial Results for 9 Months Ended Dec 31
    Consolidated Financial Results for 9 Months Ended Dec 31

    13 Feb 2025

    // PRESS RELEASE

    https://www.towayakuhin.co.jp/english/assets/result69c.pdf

    PRESS RELEASE
    13 Feb 2025
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    Towa Pharmaceutical Integrated Report 2024
    Towa Pharmaceutical Integrated Report 2024

    06 Jan 2025

    // PRESS RELEASE

    https://www.towayakuhin.co.jp/english/assets/En2024mihiraki.pdf

    PRESS RELEASE
    06 Jan 2025
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    FDF Dossiers

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    01

    Brand Name : ACETAZOLAMIDE

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAZOLAMIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET;ORAL

    Brand Name : ACETAZOLAMIDE

    Dosage Strength : 250MG

    Packaging :

    Approval Date : 2020-04-30

    Application Number : 207503

    Regulatory Info : DISCN

    Registration Country : USA

    Breckenridge Pharmaceutical

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    02

    Brand Name : ACETAZOLAMIDE

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAZOLAMIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET;ORAL

    Brand Name : ACETAZOLAMIDE

    Dosage Strength : 125MG

    Packaging :

    Approval Date : 2020-04-30

    Application Number : 207503

    Regulatory Info : DISCN

    Registration Country : USA

    Breckenridge Pharmaceutical

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    Market
    Place

    03

    Brand Name : ACICLOVIR THINKS

    Japan
    arrow
    euroPLX 88 Lisbon
    Attending
    • fda
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    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

    Regulatory Info :

    Registration Country : Italy

    Acyclovir

    Towa Pharmaceutical

    Dosage Form : Tablets

    Brand Name : ACICLOVIR THINKS

    Dosage Strength : 800 mg

    Packaging : 35 UNITS 800 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Towa Pharmaceutical

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    Market
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    04

    Brand Name : ACICLOVIR THINKS PHA...

    Japan
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    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

    Regulatory Info :

    Registration Country : Italy

    Acyclovir

    Towa Pharmaceutical

    Dosage Form : Tablets

    Brand Name : ACICLOVIR THINKS PHARMA

    Dosage Strength : 400 mg

    Packaging : 25 UNITS 400 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Towa Pharmaceutical

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    Market
    Place

    05

    Brand Name : ACICLOVIR THINKS PHA...

    Japan
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    euroPLX 88 Lisbon
    Attending
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    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

    Regulatory Info :

    Registration Country : Italy

    Acyclovir

    Towa Pharmaceutical

    Dosage Form : Tablets

    Brand Name : ACICLOVIR THINKS PHARMA

    Dosage Strength : 800 mg

    Packaging : 35 UNITS 800 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Towa Pharmaceutical

    Product
    Web Link

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    Market
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    06

    Brand Name : ACICLOVIR THINKS PHA...

    Japan
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    Attending
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    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

    Regulatory Info :

    Registration Country : Italy

    Acyclovir

    Towa Pharmaceutical

    Dosage Form : Tablets

    Brand Name : ACICLOVIR THINKS PHARMA

    Dosage Strength : 200 mg

    Packaging : 25 UNITS 200 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Towa Pharmaceutical

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    07

    Brand Name : ALENDRONATE AND CHOL...

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    Regulatory Info :

    Registration Country : Italy

    Alendronic acid; Cholecalciferol

    Towa Pharmaceutical

    Dosage Form : Tablets

    Brand Name : ALENDRONATE AND CHOLECALC...

    Dosage Strength : 70 mg+5600

    Packaging : 4 UNITS 70 MG/5600 IU - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Towa Pharmaceutical

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    08

    Brand Name : ALFUZOSIN THINK

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    Regulatory Info :

    Registration Country : Italy

    Alfuzosin

    Towa Pharmaceutical

    Dosage Form : Extended Release Tablets

    Brand Name : ALFUZOSIN THINK

    Dosage Strength : 10 mg

    Packaging : 30 UNITS 10 MG - ORAL USE (PROLONGED RELEASE)

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Towa Pharmaceutical

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    09

    Brand Name : HALOPERIDOL THINK

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    Regulatory Info :

    Registration Country : Italy

    Aloperidolo

    Towa Pharmaceutical

    Dosage Form : Oral Drops, Solution

    Brand Name : HALOPERIDOL THINK

    Dosage Strength : 2 mg/ml

    Packaging : 30 ML 2 MG/ML - USO ORALE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Towa Pharmaceutical

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    10

    Brand Name : AMITRIPTYLINE HYDROC...

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    Regulatory Info : RX

    Registration Country : USA

    AMITRIPTYLINE HYDROCHLORIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET;ORAL

    Brand Name : AMITRIPTYLINE HYDROCHLORI...

    Dosage Strength : 25MG

    Packaging :

    Approval Date : 2022-06-06

    Application Number : 216243

    Regulatory Info : RX

    Registration Country : USA

    Breckenridge Pharmaceutical

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    FDA Orange Book

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    01

    Brand Name : ACETAZOLAMIDE

    U.S.A
    BPI Europe
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    RLD : No

    TE Code :

    ACETAZOLAMIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAZOLAMIDE

    Dosage Strength : 125MG

    Approval Date : 2020-04-30

    Application Number : 207503

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Breckenridge Pharmaceutical

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    02

    Brand Name : ACETAZOLAMIDE

    U.S.A
    BPI Europe
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    RLD : No

    TE Code :

    ACETAZOLAMIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAZOLAMIDE

    Dosage Strength : 250MG

    Approval Date : 2020-04-30

    Application Number : 207503

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Breckenridge Pharmaceutical

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    03

    Brand Name : AMITRIPTYLINE HYDROC...

    U.S.A
    BPI Europe
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    RLD : No

    TE Code : AB

    AMITRIPTYLINE HYDROCHLORIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMITRIPTYLINE HYDROCHLOR...

    Dosage Strength : 10MG

    Approval Date : 2022-06-06

    Application Number : 216243

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Breckenridge Pharmaceutical

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    04

    Brand Name : AMITRIPTYLINE HYDROC...

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    RLD : No

    TE Code : AB

    AMITRIPTYLINE HYDROCHLORIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMITRIPTYLINE HYDROCHLOR...

    Dosage Strength : 25MG

    Approval Date : 2022-06-06

    Application Number : 216243

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Breckenridge Pharmaceutical

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    05

    Brand Name : AMITRIPTYLINE HYDROC...

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    RLD : No

    TE Code : AB

    AMITRIPTYLINE HYDROCHLORIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMITRIPTYLINE HYDROCHLOR...

    Dosage Strength : 50MG

    Approval Date : 2022-06-06

    Application Number : 216243

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Breckenridge Pharmaceutical

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    06

    Brand Name : AMITRIPTYLINE HYDROC...

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    RLD : No

    TE Code : AB

    AMITRIPTYLINE HYDROCHLORIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMITRIPTYLINE HYDROCHLOR...

    Dosage Strength : 75MG

    Approval Date : 2022-06-06

    Application Number : 216243

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Breckenridge Pharmaceutical

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    07

    Brand Name : AMITRIPTYLINE HYDROC...

    U.S.A
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    RLD : No

    TE Code : AB

    AMITRIPTYLINE HYDROCHLORIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMITRIPTYLINE HYDROCHLOR...

    Dosage Strength : 100MG

    Approval Date : 2022-06-06

    Application Number : 216243

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Breckenridge Pharmaceutical

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    08

    Brand Name : AMITRIPTYLINE HYDROC...

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    RLD : No

    TE Code : AB

    AMITRIPTYLINE HYDROCHLORIDE

    Breckenridge Pharmaceutical

    Dosage Form : TABLET; ORAL

    Proprietary Name : AMITRIPTYLINE HYDROCHLOR...

    Dosage Strength : 150MG

    Approval Date : 2022-06-06

    Application Number : 216243

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Breckenridge Pharmaceutical

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    Brand Name : APIXABAN

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    RLD : No

    TE Code :

    APIXABAN

    Breckenridge Pharmaceutical

    Dosage Form : TABLET; ORAL

    Proprietary Name : APIXABAN

    Dosage Strength : 2.5MG

    Approval Date : 2021-07-26

    Application Number : 209845

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Breckenridge Pharmaceutical

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    Brand Name : APIXABAN

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    RLD : No

    TE Code :

    APIXABAN

    Breckenridge Pharmaceutical

    Dosage Form : TABLET; ORAL

    Proprietary Name : APIXABAN

    Dosage Strength : 5MG

    Approval Date : 2021-07-26

    Application Number : 209845

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Breckenridge Pharmaceutical

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