Product-Specific Guidances for Generic Drug Development

Disclaimer: Due to April 2019 systemwide upgrades to www.fda.gov, the filenames for product-specific guidances on this web page may not match the corresponding guidance titles. In such cases, the name on the document correctly identifies the title of the guidance. These discrepancies will be corrected as soon as possible.


To successfully develop and manufacture a generic drug product, an applicant should consider that their product is expected to be: pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use; bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient; and, consequently, therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its reference listed drug.

According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate bioequivalence depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct bioequivalence testing using the most accurate, sensitive, and reproducible approach available among those set forth in 21 CFR 320.24. As the initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).

To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific guidances describing the Agency's current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs.

FDA publishes these product-specific guidances to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, affordable generic drugs.

These guidances are published in an incremental manner and listed below in alphabetical order according to the active ingredient's name. The most recently published guidances (new and revised) are listed below.

Additionally, as part of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), FDA will publish guidances for reference listed drugs that are (1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to the earliest lawful ANDA filing date. 1 This goal does not include complex products as defined in the GDUFA II Commitment Letter. FDA will strive to issue guidance for a complex product as soon as scientific recommendations are available.

In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or bioequivalence (BE) and/or bioavailability (BA) studies involving human subjects in support of an ANDA should refer to the current RLD labeling, including BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. This information should be considered during study design and conduct; including attention to appropriate subject screening and selection, inclusion and exclusion criteria, and appropriate clinical safety monitoring.

Some of the product-specific guidances include discussion regarding data formats. Please note that under section 745A(a) of the Federal Food, Drug, and Cosmetic Act, separate Agency-wide guidances specify the electronic formats, subject matter, and scope of applicability for certain submissions, including submissions to ANDAs. As these are finalized guidances and subject to described timetables for implementation, these guidances are binding and the electronic format(s) specified must be used for submissions to ANDAs. Questions and general information regarding the preparation of submissions in electronic format may be directed to CDER at esub@fda.hhs.gov. Questions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov.

COMMENTS: The Agency is seeking feedback and considers comments to the docket on these guidances. You may submit comments on any guidance at any time as follows: Submit electronic comments to Docket FDA-2007-D-0369. For further information on submitting electronic comments, refer to the regulations.gov website (https://www.regulations.gov/help). You may also mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions received must include the Docket No. [FDA-2007-D-0369]. Please contact the Regulations.gov Help Desk at 1-877-378-5457 (toll free) for assistance regarding submissions.

The FDA posts plans for issuing new or revised product-specific guidances on the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page.

For additional information on development of generic drug products, please refer to FDA’s biopharmaceutics guidances.

1GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Commitment Letter)

 

 

 

Total number of currently published PSGs: 1921

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


63 record(s) found for 'I'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Ibandronate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibandronate_tab_21455_RC11-06.pdf Final Oral Tablet 021455 05/2008
Ibrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205552.pdf Draft Oral Capsule 205552 03/2020
Ibrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210563.pdf Draft Oral Tablet 210563 09/2019
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_Oral Suspension_RLD 074978_RC09-16.pdf Draft Oral Suspension 019842 10/2016
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_capsule_020402_RC03-15.pdf Draft Oral Capsule 020402 03/2015
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_caps_21472_RC11-10.pdf Draft Oral Capsule 021472 11/2010
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_tabs_75682_RC3-10.pdf Draft Oral Tablet 075682 03/2010
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_tabs_OTC_19012_RC3-10.pdf Draft Oral Tablet 019012 03/2010
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_susp_20516_19842_OTC_RC10-08.pdf Draft Oral Suspension 020516 07/2009
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_suspdrp_20603_OTC_RC10-08.pdf Draft Oral Suspension, Drops 020603 10/2008
Ibuprofen Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_sodium_tab_201803_RC12-14.pdf Draft Oral Tablet 201803 12/2014
Ibuprofen; Phenylephrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen;_Phenlyephrine_HCl_tab_22565_RC10-11.pdf Draft Oral Tablet 022565 10/2011
Ibuprofen; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen; Pseudoephrine Hcl_oral capsule_RLD 21374_RC12-16.pdf Draft Oral Capsule 021374 12/2016
Ibuprofen; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen-Pseudoephedrine HCl susp 21128 RC11-01.pdf Draft Oral Suspension 021128 08/2007
Ibuprofen; Pseudoephedrine hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen-Pseudoephedrine Hydrochloride Oral Tablets NDA 019771 RC 09-2018.pdf Draft Oral Tablet 019771 09/2018
Icosapent Ethyl https://www.accessdata.fda.gov/drugsatfda_docs/psg/Icosapent Ethyl_oral capsule_RLD 202057_RV09-16.pdf Draft Oral Capsule 202057 10/2016
Idelalisib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Idelalisib_oral tablet_205858_RC09-15.pdf Draft Oral Tablet 205858 09/2015
Iloperidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Iloperidone_tab_22192_RC11-10.pdf Draft Oral Tablet 022192 11/2010
Imatinib Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Imatinib_Mesylate_tab_21588_RV07-14.pdf Draft Oral Tablet 021588 07/2014
Imipramine Pamoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Imipramine_Pamoate_cap_17090_RC2-11.pdf Draft Oral Capsule 017090 02/2011
Imiquimod https://www.accessdata.fda.gov/drugsatfda_docs/psg/Imiquimod Topical Cream 2.5_NDA 022483 RV Feb 2019.pdf Draft Topical Cream 2.5% 022483 02/2019
Imiquimod https://www.accessdata.fda.gov/drugsatfda_docs/psg/Imiquimod Topical Cream 3.75_NDA 022483 RV Feb 2019.pdf Draft Topical Cream 3.75% 022483 02/2019
Imiquimod https://www.accessdata.fda.gov/drugsatfda_docs/psg/Imiquimod Topical Cream NDA 020723 RV Feb 2019.pdf Draft Topical Cream 020723 02/2019
Indacaterol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Indacaterol maleate_inhalation powder_RLD 22383_RC04-16.pdf Draft Inhalation Powder 022383 04/2016
Indapamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018538.pdf Draft Oral Tablet 018538 11/2019
Indinavir Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Indinavir_Sulfate_cap_20685_RC4-05.pdf Final Oral Capsule 020685 05/2008
Indocyanine Green https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211580.pdf Draft Intravenous, Interstitial Powder 211580 11/2019
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017814.pdf Draft Rectal Suppository 017814 08/2021
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Indomethacin_oral capsule_204768_RC06-15.pdf Draft Oral Capsule 204768 06/2015
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Indomethacin_cap_70624_18858_RC2-10.pdf Draft Oral Capsule 016059 02/2010
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Indomethacin_ERcap_74464_RC2-10.pdf Draft Oral Capsule, Extended Release 018185 02/2010
Ingenol Mebutate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ingenol Mebutate Topical Gel 0.05_NDA 202833 RV Feb 2019.pdf Draft Topical Gel 0.050% 202833 02/2019
Ingenol Mebutate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ingenol Mebutate Topical Gel 0.015_NDA 202833 RV Feb 2019.pdf Draft Topical Gel 0.015% 202833 02/2019
Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020393.pdf Draft Nasal Spray, Metered 020393 020394 08/2021
Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021527.pdf Draft Inhalation Aerosol, Metered 021527 03/2021
Irbesartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Irbesartan_tab_20757_RC5-06.pdf Final Oral Tablet 020757 05/2008
Iron Dextran https://www.accessdata.fda.gov/drugsatfda_docs/psg/Iron dextran_injetion_RLD 017441_RC09-16.pdf Draft Injectable Injection 017441 10/2016
Isavuconazonium Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isavuconazonium sulfate_ oral capsule_RLD 207500_RC04-16.pdf Draft Oral Capsule 207500 04/2016
Isocarboxazid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isocarboxazid Oral Tablet NDA 011961 RC Feb 2019.pdf Draft Oral Tablet 011961 02/2019
Isoniazid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isoniazid_oral tablet_RLD 08678_RC7-08.pdf Draft Oral Tablet 008678 07/2008
Isoniazid; Pyrazinamide; Rifampin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050705.pdf Draft Oral Tablet 050705 11/2019
Isosorbide Dinitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019790.pdf Draft Oral Capsule, Extended Release 019790 11/2019
Isosorbide Dinitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isosorbide Dinitrate_Oral tablet_NDA 012093_RV Nov 2018.pdf Draft Oral Tablet 012093 11/2018
Isosorbide Dinitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isosorbide_Dinitrate_tab_087946_RC03-15.pdf Draft Oral Tablet 087946 03/2015
Isosorbide Mononitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isosorbide_Mononitrate_ERtab_20225_RC10-05.pdf Final Oral Tablet, Extended Release 020225 05/2008
Isotretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018662.pdf Draft Oral Capsule 076135 018662 11/2020
Isotretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021951.pdf Draft Oral Capsule 021951 11/2020
Isradipine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isradipine_cap_77317_RC10-04.pdf Final Oral Capsule 019546 05/2008
Isradipine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isradipine_ERtab_20336_RC7-05.pdf Final Oral Tablet, Extended Release 020336 05/2008
Istradefylline https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022075.pdf Draft Oral Tablet 022075 03/2021
Itraconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Itraconazole_Tab_22484_RC06-12.pdf Draft Oral Tablet 022484 06/2012
Itraconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Itraconazole_cap_20083_RC5-06.pdf Draft Oral Capsule 020083 05/2007
Ivabradine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ivabradine hydrochloride_oral tablet_RLD 206143_RC04-16.pdf Draft Oral Tablet 206143 04/2016
Ivacaftor https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ivacaftor_oral granule_RLD 207925_RC04-16.pdf Draft Oral Granules 207925 04/2016
Ivacaftor https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ivacaftor_Tablet_203188_RC03-15.pdf Draft Oral Tablet 203188 03/2015
Ivacaftor; Ivacaftor, Tezacaftor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210491.pdf Draft Oral Tablet, Tablet 210491 03/2021
Ivacaftor; Lumacaftor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211358.pdf Draft Oral Granule 211358 03/2020
Ivacaftor;Lumacaftor https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ivacaftor-Lumacaftor Oral Tablet NDA 206038 RV Feb 2019.pdf Draft Oral Tablet 206038 02/2019
Ivermectin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ivermectin Topical Cream 1 NDA 206255 PSG Page RV May 2019.pdf Draft Topical Cream 206255 05/2019
Ivermectin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ivermenctin_tabs_50742_RC03-12.pdf Draft Oral Tablet 050742 03/2012
Ivermectin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ivermectin topical lotion NDA 202736 RC 09-2018.pdf Draft Topical Lotion 202736 09/2018
Ivosidenib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211192.pdf Draft Oral Tablet 211192 06/2020
Ixazomib Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ixazomibe citrate_oral capsule_NDA 208462_RC11-17.pdf Draft Oral Capsule 208462 02/2018

Newly Added Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202408.pdf Draft Ophthalmic Ointment 202408 08/2021
Albuterol Sulfate; Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf Draft Inhalation Spray, Metered 021747 08/2021
Amisulpride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209510.pdf Draft Intravenous Solution 209510 08/2021
Avapritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212608.pdf Draft Oral Tablet 212608 08/2021
Carbinoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008915.pdf Draft Oral Tablet 008915 08/2021
Cefiderocol Sulfate Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209445.pdf Draft Intravenous Powder 209445 08/2021
Copper Dotatate Cu-64 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213227.pdf Draft Intravenous Solution 213227 08/2021
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214278.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/2021
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021166.pdf Draft Transdermal Gel, Metered 021166 08/2021
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204017.pdf Draft Transdermal System 204017 08/2021
Fostemsavir Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212950.pdf Draft Oral Tablet, Extended Release 212950 08/2021
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017814.pdf Draft Rectal Suppository 017814 08/2021
Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020393.pdf Draft Nasal Spray, Metered 020393 020394 08/2021
Lasmiditan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211280.pdf Draft Oral Tablet 211280 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021343.pdf Draft Subcutaneous Powder 021343 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208219.pdf Draft Ophthalmic Gel 208219 08/2021
Olodaterol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf Draft Inhalation Spray, Metered 203108 08/2021
Osilodrostat Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212801.pdf Draft Oral Tablet 212801 08/2021
Ozanimod Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209899.pdf Draft Oral Capsule 209899 08/2021
Paliperidone Palmitate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207946.pdf Draft Intramuscular Suspension, Extended Release 207946 08/2021
Semaglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213051.pdf Draft Oral Tablet 213051 08/2021
Sufentanil Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209128.pdf Draft Sublingual Tablet 209128 08/2021
Tazemetostat Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211723.pdf Draft Oral Tablet 211723 08/2021

Newly Revised Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Bexarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021055.pdf Draft Oral Capsule 021055 08/2021
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021324.pdf Draft Oral Capsule, Delayed Release 021324 08/2021
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022291.pdf Draft Oral Tablet 022291 08/2021
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207027.pdf Draft Oral For Suspension 207027 08/2021
Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 08/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205109.pdf Draft Oral Tablet, Chewable 205109 09/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021135.pdf Draft Intravenous Injectable 021135 09/2021
Letrozole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020726.pdf Draft Oral Tablet 020726 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019732.pdf Draft Injection Injectable 019732 020011 020263 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020517.pdf Draft Injection Injectable 020517 020708 08/2021
Liothyronine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010379.pdf Draft Oral Tablet 010379 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf Draft Ophthalmic Suspension/Drops 020583 08/2021
Nystatin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060578.pdf Draft Topical Powder 065203 08/2021
Orlistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020766.pdf Draft Oral Capsule 020766 021887 08/2021
Paclitaxel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021660.pdf Draft IV Infusion For Suspension 021660 08/2021
Podofilox https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020529.pdf Draft Topical Gel 020529 08/2021
Sodium Zirconium Cyclosilicate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207078.pdf Draft Oral For Suspension 207078 08/2021
Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021184-Cre-0.05P.pdf Draft Topical Cream 0.05% 021184 08/2021

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