Product-Specific Guidances for Generic Drug Development

Disclaimer: Due to April 2019 systemwide upgrades to, 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 Questions regarding submission of datasets to CDER may be sent to

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 website ( 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 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

114 record(s) found for 'P'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Paclitaxel Draft IV Infusion For Suspension 021660 08/2021
Palbociclib capsule_RLD 207103_RC04-16.pdf Draft Oral Capsule 207103 04/2016
Paliperidone Draft Oral Tablet, Extended Release 021999 03/2015
Paliperidone Palmitate palmitate inj ER suspension RLD 22264 RV07-16.pdf Draft Injection, Intramuscular Suspension, Extended Release 022264 06/2016
Paliperidone Palmitate Draft Intramuscular Suspension, Extended Release 207946 08/2021
Palonosetron Hydrochloride Draft Oral Capsule 022233 12/2010
Panobinostat Lactate lactate_oral capsule_RLD 205353_RC12-16.pdf Draft Oral Capsule 205353 12/2016
Pantoprazole Sodium Final Oral Tablet, Delayed Release 020987 05/2008
Pantoprazole Sodium sodium_oral DR suspension_NDA 022020_RV11-17.pdf Draft Oral Powder For Suspension, Delayed Release 022020 02/2018
Paricalcitol Draft Oral Capsule 021606 11/2007
Paroxetine Hydrochloride ER tablet_RLD 020936_RV06-16.pdf Draft Oral Tablet, Extended Release 020936 06/2016
Paroxetine Hydrochloride Draft Oral Tablet 020031 08/2008
Paroxetine Mesylate mesylate cap 204516_RC07-14.pdf Draft Oral Capsule 204516 07/2014
Paroxetine mesylate Mesylate Oral Tablets NDA NDA 021299 RC Feb 2019.pdf Draft Oral Tablet 021299 02/2019
Pazopanib Hydrochloride Draft Oral Tablet 022465 03/2021
Penbutolol Sulfate Draft Oral Tablet 018976 09/2010
Penciclovir topical cream NDA 020629 RC 09-2018.pdf Draft Topical Cream 020629 09/2018
Penicillamine Tablet_NDA 19854_RC Oct 2018.pdf Draft Oral Tablet 019854 11/2018
Penicillamine Draft Oral Capsule 019853 08/2008
Penicillin G Benzathine Draft Injection Injectable 050141 03/2021
Penicillin V Potassium Draft Oral Tablet 064071 06/2011
Pentosan Polysulfate Sodium Draft Oral Capsule 020193 05/2021
Perampanel suspension_RLD 208277_RC12-16.pdf Draft Oral Suspension 208277 12/2016
Perampanel Draft Oral Tablet 202834 04/2014
Perflutren Liposomal Injection RLD 021064 RC 09-2018 .pdf Draft Intravenous Injectable 021064 09/2018
Perindopril Erbumine Final Oral Tablet 020184 05/2008
Permethrin cream_RLD 019855_RC08-17.pdf Draft Topical Cream 019855 10/2017
Perphenazine Draft Oral Tablet 010775 02/2010
Pexidartinib Hydrochloride Draft Oral Capsule 211810 05/2021
Phendimetrazine Tartrate Final Oral Capsule, Extended Release 018074 10/2011
Phendimetrazine Tartrate Final Oral Tablet 085272 10/2011
Phenelzine Sulfate Draft Oral Tablet 011909 04/2010
Phenoxybenzamine Hydrochloride Draft Oral Capsule 008708 12/2012
Phentermine Hydrochloride Draft Oral Tablet, Orally Disintegrating 202088 11/2013
Phentermine Hydrochloride Final Oral Capsule 087190 088023 10/2011
Phentermine Hydrochloride Final Oral Tablet 085128 088605 10/2011
Phentermine Hydrochloride;Topiramate Draft Oral Capsules, Extended Release 022580 06/2013
Phenytoin chewable tablet_ANDA 084427_RV03-17.pdf Draft Oral Tablet, Chewable 084427 05/2017
Phenytoin suspension_RLD 008762_RV03-17.pdf Draft Oral Suspension 008762 05/2017
Phenytoin Sodium Draft Oral Capsule, Extended Release 040298 12/2014
Phenytoin Sodium Draft Oral Capsule, Extended Release 084349 12/2014
Phytonadione tablet_RLD010104_RV01-16.pdf Draft Oral Tablet 010104 01/2016
Phytonadione Draft Injectable Injection 012223 09/2012
Pilocarpine Hydrochloride Final Oral Tablet 020237 05/2008
Pilocarpine hydrochloride HYDROCHLORIDE ophthalmic solution NDA 200890 RC 09-2018.pdf Draft Ophthalmic Solution 200890 09/2018
Pimavanserin Tartrate Draft Oral Capsule 210793 11/2019
Pimavanserin Tartrate Draft Oral Tablet 207318 11/2020
Pimecrolimus Draft Topical Cream 021302 11/2019
Pimozide tablet_NDA 017473_RV05-17.pdf Draft Oral Tablet 017473 07/2017
Pindolol Draft Oral Tablet 018285 04/2014
Pioglitazone Hydrochloride Draft Oral Tablet 021073 12/2009
Pirfenidone tablet_NDA 208780_RC08-17.pdf Draft Oral Tablet 208780 10/2017
Pirfenidone capsule_022535_RC09-15.pdf Draft Oral Capsule 022535 09/2015
Piroxicam Draft Oral Capsule 018147 12/2012
Pitavastatin Draft Oral Tablet 022363 06/2011
Pitavastatin magnesium Magnesium Oral Tablets NDA 208379 RC 09-2018.pdf Draft Oral Tablet 208379 09/2018
Pitavastatin sodium Sodium Oral Tablet NDA 209875 RC 09-2018.pdf Draft Oral Tablet 209875 09/2018
Pitolisant Hydrochloride Draft Oral Tablet 211150 05/2021
Plazomicin Sulfate Draft Intravenous Solution 210303 09/2019
Plecanatide Draft Oral Tablet 208745 09/2019
Podofilox Draft Topical Gel 020529 08/2021
Podofilox Draft Topical Solution 019795 08/2011
Pomalidomide capsule_RLD 204026_RV06-16.pdf Draft Oral Capsule 204026 06/2016
Ponatinib Hydrochloride hydrochloride_oral tablet_203469_RC09-15.pdf Draft Oral Tablet 203469 09/2015
Posaconazole Draft Oral Suspension 022003 11/2007
Posaconazole Draft Oral Tablet, Delayed Release 205053 12/2014
Potassium Chloride Draft Oral Tablet, Extended Release 018279 03/2015
Potassium Chloride Draft Oral Tablet, Extended Release 019123 10/2011
Potassium Chloride Draft Oral Tablet, Extended Release 019439 09/2011
Potassium Chloride Draft Oral Capsules, Extended Release 018238 08/2011
Potassium Citrate citrate_oral ER tablet_NDA 19071_RV11-17.pdf Draft Oral Tablet, Extended Release 019071 02/2018
Pramipexole Dihydrochloride Draft Oral Tablet 020667 12/2008
Pramipexole Dihydrochloride Draft Oral Tablet, Extended Release 022421 07/2010
Prasterone insert_NDA 208470_RC11-17.pdf Draft Vaginal Insert 208470 02/2018
Prasugrel Hydrochloride hydrochloride_Oral tablet_022307_RV06-15.pdf Draft Oral Tablet 022307 06/2015
Pravastatin Sodium Final Oral Tablet 019898 05/2008
Praziquantel Draft Oral Tablet 018714 03/2015
Prazosin Hydrochloride HCl_oral capsule_RLD 17442_RC12-16.pdf Draft Oral Capsule 017442 12/2016
Prednicarbate ointment_RLD 19568_RC06-16.pdf Draft Topical Ointment 019568 06/2016
Prednisolone Draft Oral Tablet 080354 11/2010
Prednisolone Acetate acetate Ophthalmic suspension RLD 017011 PSG Page RV May 2019.pdf Draft Ophthalmic Suspension, Drops 017011 05/2019
Prednisolone Acetate Draft Oral Suspension 022067 02/2010
Prednisolone Sodium Phosphate Draft Oral Tablet, Orally Disintegrating 021959 11/2019
Prednisone Draft Oral Tablet, Delayed Release 202020 11/2013
Prednisone tablet_RLD084283_84122_87800_87801_87342_80352 RC01-16.pdf Draft Oral Tablet 009766 009986 01/2016
Pregabalin Final Oral Capsule 021446 10/2011
Pregabalin oral extended release tablet NDA 209501 RC 09-2018.pdf Draft Oral Tablet, Extended Release 209501 09/2018
Pretomanid Draft Oral Tablet 212862 11/2020
Primaquine Phosphate tab_008316_RC06-15.pdf Draft Oral Tablet 008316 06/2015
Primidone Tablets NDA 009170 PSG Page RC May 2019.pdf Draft Oral Tablet 009170 05/2019
Procarbazine Hydrochloride Draft Oral Capsule 016785 03/2012
Prochlorperazine Suppository_RLD 040058_RC09-16.pdf Draft Rectal Suppository 040058 10/2016
Prochlorperazine Maleate Draft Oral Tablet 010571 11/2020
Progesterone gel_RLD 020701_RC10-15.pdf Draft Vaginal Gel 020701 10/2015
Progesterone Draft Vaginal Insert 022057 09/2012
Progesterone Draft Oral Capsule 019781 02/2011
Promethazine Hydrochloride Draft Rectal Suppository 010926 07/2014
Promethazine Hydrochloride Draft Rectal Suppository 011689 07/2014
Promethazine Hydrochloride 84176_84234_RC2-10.pdf Draft Oral Tablet 007935 02/2010
Propafenone Hydrochloride HCL_oral ER capsule_NDA 21416_RV03-17.pdf Draft Oral Capsule, Extended Release 021416 05/2017
Propafenone Hydrochloride hydrochloride_oral tablet_NDA 019151_RV07-17.pdf Draft Oral Tablet 019151 07/2017
Propofol injection_RLD 19627_RC06-16.pdf Draft Injectable Injection 019627 06/2016
Propranolol Hydrochloride Draft Oral Tablet 016418 11/2020
Propranolol Hydrochloride Draft Oral Capsule, Extended Release 018553 11/2020
Propranolol Hydrochloride Draft Oral Capsule, Extended Release 021438 11/2020
Propylthiouracil Draft Oral Tablet 006188 03/2012
Protriptyline Hydrochloride Draft Oral Tablet 073645 12/2010
Prucalopride Succinate Draft Oral Tablet 210166 06/2020
Pseudoephedrine Hydrochloride HCl_Oral_ER Tab_RLD 073585_RC06-16.pdf Draft Oral Tablet, Extended Release 073585 06/2016
Pseudoephedrine Hydrochloride Draft Oral Tablet, Extended Release 020021 08/2010
Pyrazinamide tablet_RLD 080157_RC09-16.pdf Draft Oral Tablet 080157 10/2016
Pyridostigmine Bromide Draft Oral Tablet, Extended Release 011665 08/2011
Pyridostigmine Bromide Final Oral Tablet 009829 10/2011
Pyrimethamine tab_008578_RC03-15.pdf Draft Oral Tablet 008578 03/2015

Newly Added Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acyclovir Draft Ophthalmic Ointment 202408 08/2021
Albuterol Sulfate; Ipratropium Bromide Draft Inhalation Spray, Metered 021747 08/2021
Amisulpride Draft Intravenous Solution 209510 08/2021
Avapritinib Draft Oral Tablet 212608 08/2021
Carbinoxamine Maleate Draft Oral Tablet 008915 08/2021
Cefiderocol Sulfate Tosylate Draft Intravenous Powder 209445 08/2021
Copper Dotatate Cu-64 Draft Intravenous Solution 213227 08/2021
Esomeprazole Magnesium Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/2021
Estradiol Draft Transdermal Gel, Metered 021166 08/2021
Ethinyl Estradiol; Levonorgestrel Draft Transdermal System 204017 08/2021
Fostemsavir Tromethamine Draft Oral Tablet, Extended Release 212950 08/2021
Indomethacin Draft Rectal Suppository 017814 08/2021
Ipratropium Bromide Draft Nasal Spray, Metered 020393 020394 08/2021
Lasmiditan Succinate Draft Oral Tablet 211280 08/2021
Leuprolide Acetate Draft Subcutaneous Powder 021343 08/2021
Loteprednol Etabonate Draft Ophthalmic Gel 208219 08/2021
Olodaterol Hydrochloride Draft Inhalation Spray, Metered 203108 08/2021
Osilodrostat Phosphate Draft Oral Tablet 212801 08/2021
Ozanimod Hydrochloride Draft Oral Capsule 209899 08/2021
Paliperidone Palmitate Draft Intramuscular Suspension, Extended Release 207946 08/2021
Semaglutide Draft Oral Tablet 213051 08/2021
Sufentanil Citrate Draft Sublingual Tablet 209128 08/2021
Tazemetostat Hydrobromide 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 Draft Oral Capsule 021055 08/2021
Budesonide Draft Oral Capsule, Delayed Release 021324 08/2021
Eltrombopag Olamine Draft Oral Tablet 022291 08/2021
Eltrombopag Olamine Draft Oral For Suspension 207027 08/2021
Ferric Citrate Draft Oral Tablet 205874 08/2021
Ferric Oxyhydroxide Draft Oral Tablet, Chewable 205109 09/2021
Ferric Oxyhydroxide Draft Intravenous Injectable 021135 09/2021
Letrozole Draft Oral Tablet 020726 08/2021
Leuprolide Acetate Draft Injection Injectable 019732 020011 020263 08/2021
Leuprolide Acetate Draft Injection Injectable 020517 020708 08/2021
Liothyronine Sodium Draft Oral Tablet 010379 08/2021
Loteprednol Etabonate Draft Ophthalmic Suspension/Drops 020583 08/2021
Nystatin Draft Topical Powder 065203 08/2021
Orlistat Draft Oral Capsule 020766 021887 08/2021
Paclitaxel Draft IV Infusion For Suspension 021660 08/2021
Podofilox Draft Topical Gel 020529 08/2021
Sodium Zirconium Cyclosilicate Draft Oral For Suspension 207078 08/2021
Tazarotene Draft Topical Cream 0.05% 021184 08/2021

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English