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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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


54 record(s) found for 'R'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Rabeprazole Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rabeprazole sodium_DRcap_204736_RC02-14.pdf Draft Oral Capsule, Delayed Release 204736 04/2014
Rabeprazole Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rabeprazole_Sodium_DRTab_20973_RC12-10.pdf Draft Oral Tablet, Delayed Release 020973 12/2010
Raloxifene Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Raloxifene_HCl_tab_20815_RC8-06.pdf Final Oral Tablet 020815 05/2008
Raltegravir Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Raltegravir_potassium_chewtab_203045_RC12-14.pdf Draft Oral Tablet, Chewable 203045 12/2014
Raltegravir Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Raltgravir Potassium Oral Tablets NDA 022145 RV 09-2018.pdf Draft Oral Tablet 022145 09/2018
Ramelteon https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ramelton_tab_21782__RC3-09.pdf Final Oral Tablet 021782 10/2011
Ramipril https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ramipril_tab_22021_RC8-08.pdf Draft Oral Tablet 022021 08/2008
Ramipril https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ramipril_cap_19901_RC5-05.pdf Final Oral Capsule 019901 05/2008
Ranitidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Raniditine_tab_20520_21698 _RC11-09_OTC.pdf Draft Oral Tablet 020520 021698 11/2009
Ranitidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ranitidine_tab_18703_RC11-09.pdf Draft Oral Tablet 018703 11/2009
Ranitidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ranitidine hydrochloride_Oral capsule RLD074655_RC01-16.pdf Draft Oral Capsule 020095 01/2016
Ranitidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ranitidine_HCl_Efftab_20251_RC2-10.pdf Draft Oral Tablet, Effervescent 020251 02/2010
Ranolazine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ranolazine_ERtab_21526_RC08-10.pdf Draft Oral Tablet, Extended Release 021526 08/2010
Rasagiline Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rasagiline_Mesylate_tab_21641_RC11-09.pdf Draft Oral Tablet 021641 11/2009
Regorafenib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203085.pdf Draft Oral Tablet 203085 03/2021
Repaglinide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Repaglinide_tab_20741_RC8-08.pdf Draft Oral Tablet 020741 08/2008
Reserpine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Reserpine_Oral tablets_NDA 009838_RC Oct 2018.pdf Draft Oral Tablet 009838 11/2018
Revefenacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210598.pdf Draft Inhalation Solution 210598 06/2020
Ribavirin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ribavirin_cap_20903_RC6-05.pdf Final Oral Capsule 020903 05/2008
Ribavirin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ribavirin_tab_77456_RC5-06.pdf Final Oral Tablet 077456 05/2008
Ribociclib succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ribociclib Succinate_Oral tablet_NDA 209092_RC Oct 2018.pdf Draft Oral Tablet 209092 11/2018
Rifabutin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rifabutin_cap_50689_RC2-10.pdf Draft Oral Capsule 050689 02/2010
Rifampin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rifampin_cap_50420_ RC6-05.pdf Final Oral Capsule 050420 05/2008
Rifamycin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210910.pdf Draft Oral Tablet, Delayed Release 210910 03/2020
Rifapentine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rifapentine_oral tablet_NDA 021024_RC07-18.pdf Draft Oral Tablet 021024 07/2018
Rifaximin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rifaximin_oral tablet_NDA 022554 and 021361_RV03-17.pdf Draft Oral Tablet 021361 03/2017
Rilpivirine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rilpivirine HCl_tab_202022_RC09-12.pdf Draft Oral Tablet 202022 09/2012
Riluzole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Riluzole_tab_20599_RC11-04.pdf Final Oral Tablet 020599 05/2008
Rimexolone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rimexolone_ophthalmic suspension_RLD 020474_RV06-16.pdf Draft Ophthalmic Drops, Suspension 020474 06/2016
Riociguat https://www.accessdata.fda.gov/drugsatfda_docs/psg/Riociguat_oral tablet_RLD204819_RC01-16.pdf Draft Oral Tablet 204819 01/2016
Risedronate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Risedronate_Na_DR_tabs_22560_RV12-12.pdf Draft Oral Tablet, Delayed Release 022560 12/2012
Risedronate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Risedronate_Sodium_tab_20835_RC8-05.pdf Draft Oral Tablet 020835 12/2008
Risperidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Risperidone_ODTab_21444_RC07-10.pdf Draft Oral Tablet, Orally Disintegrating 021444 07/2010
Risperidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Risperidone_intramuscular injection_RLD 21346_RV08-16 separate post.pdf Draft Intramuscular Injection 021346 08/2016
Risperidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Risperidone_tab_20272_RC10-05.pdf Draft Oral Tablet 020272 05/2007
Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ritonavir_tab_22417_RC06-11.pdf Draft Oral Tablet 022417 06/2011
Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ritonavir_cap_20945_RC5-05.pdf Final Oral Capsule 020945 05/2008
Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ritonavir_oral powder_NDA 209512_RC07-18.pdf Draft Oral Powder 209512 07/2018
Rivaroxaban https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022406.pdf Draft Oral Tablet 022406 08/2020
Rivastigmine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022083.pdf Draft Transdermal Film, Extended Release 022083 11/2019
Rivastigmine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rivastigmine tartrate_oral capsules_RLD 020823_RV01-16.pdf Draft Oral Capsule 020823 01/2016
Rizatriptan Benzoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rizatriptan_benzoate_ODT_20865_RC04-13.pdf Draft Oral Tablet, Orally Disintegrating 020865 04/2013
Rizatriptan Benzoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rizatriptan_Benzoate_tab_20864_RC10-04.pdf Final Oral Tablet 020864 05/2008
Roflumilast https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022522.pdf Draft Oral Tablet 022522 11/2019
Rolapitant Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rolapitant hydrochloride_oral tablet_RLD 206500_RC09-16.pdf Draft Oral Tablet 206500 10/2016
Ropinirole Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ropinirole HCL_oral ER tablet_NDA 022008_RV08-17.pdf Draft Oral Tablet, Extended Release 022008 10/2017
Ropinirole Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ropinirole_IR_Tablets_020658_RC07-14.pdf Draft Oral Tablet 020658 07/2014
Rosiglitazone Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rosiglitazone_Maleate_tab_21071_RC1-05.pdf Final Oral Tablet 021071 05/2008
Rosuvastatin Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rosuvastatin_Calcium_tab_21366_RC3-05.pdf Final Oral Tablet 021366 05/2008
Rotigotine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021829.pdf Draft Transdermal Film, Extended Release 021829 11/2019
Rucaparib Camsylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209115.pdf Draft Oral Tablet 209115 03/2021
Rufinamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rufinamide_Susp_201367_RC06-12.pdf Draft Oral Suspension 201367 06/2012
Rufinamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rufinamide_tab_21911_RC08-11.pdf Draft Oral Tablet 021911 08/2011
Ruxolitinib Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ruxolitinib Phosphate_Oral Tablet_ RLD 202192_RV01-17.pdf Draft Oral Tablet 202192 01/2017

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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