U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. PSG Database

Product-Specific Guidances for Generic Drug Development

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 RLD.

According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence (BE) for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate BE depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct BE 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 facilitate generic drug product availability and further assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, the FDA publishes product-specific guidances (PSG). PSGs describe the Agency's current thinking and expectations to develop generic drug products therapeutically equivalent to specific RLDs.

The FDA publishes PSGs to foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs.

PSGs 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.

The implementation of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 20221 (GDUFA III). with regard to issuance of PSGs is effective on October 1, 2022. Under GDUFA III, the FDA will issue PSGs consistent with the following goals:

  • For complex products1,2 approved in new drug applications (NDAs) on or after October 1, 2022, a PSG will be issued for 50 percent of such NDA products within two years after the date of approval, and for 75 percent of such NDA products within three years after the date of approval.
  • FDA will continue to develop PSGs for complex products approved prior to October 1, 2022, for which no PSG has been published.
  • For non-complex drug products approved in NDAs on or after October 1, 2022, that contain a new chemical entity (NCE) (as described in section 505(j)(5)(F)(ii) of the FD&C Act), a PSG will be issued within two years after the date of approval for 90 percent of such products.
In addition to GDUFA III PSG goals, the FDA considers several factors when prioritizing PSG development. The FDA evaluates the generic industries and other stakeholders' interest in products that do not have a PSG through controlled correspondences, public requests, and pre-ANDA meeting requests.

The FDA also evaluates drug availability and accessibility and considers public health priorities, including but not limited to, public health emergencies and drug safety and efficacy updates. In addition to these elements, the FDA continually assesses the status and outcomes of ongoing GDUFA research to ensure there are sufficient and adequate data and evidence to support the development of PSGs that align with the FDA's current scientific thinking.

Sponsors and investigators of any investigational new drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or 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.

In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or 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 PSGs 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 (www.regulations.gov). 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) or at (www.regulations.gov/support) for assistance regarding submissions.

The FDA posts plans for issuing new or revised PSGs on the Upcoming Product-Specific Guidances for Generic Drug Product Development web page

For additional information on development of generic drug products, please refer to FDA's guidance document database.

1GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III Commitment Letter)

2Classifying Approved New Drug Products and Drug-device combination Products as Complex Products for Generic Drug Development Purposes (CDER MAPP 5240.10)

Total number of currently published PSGs: 2252

Product-Specific Guidances for Specific Products Arranged by Active Ingredient

Search by Active Ingredient or by RLD or RS Number

Newly Added Guidances since November 19, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acalabrutinib Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216387.pdf Draft Oral Tablet 216387 11/19/2024
Adapalene; Benzoyl Peroxide; Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216632.pdf Draft Topical Gel 216632 11/19/2024
Allopurinol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016084-Sus.pdf Draft Oral Suspension 016084 11/19/2024
Aripiprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217006.pdf Draft Intramuscular Suspension, Extended Release 217006 11/19/2024
Aripiprazole Lauroxil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209830.pdf Draft Intramuscular Suspension, Extended Release 209830 11/19/2024
Buspirone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021190.pdf Draft Oral Capsule 021190 11/19/2024
Cantharidin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212905.pdf Draft Topical Solution 212905 11/19/2024
Cefazolin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211413.pdf Draft Intravenous Powder 211413 11/19/2024
Clonazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017533-Sus.pdf Draft Oral Suspension 017533 11/19/2024
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217469.pdf Draft Ophthalmic Solution 217469 11/19/2024
Dexamethsone; Neomycin Sulfate; Polymyxin B Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050065.pdf Draft Ophthalmic Ointment 050065 11/19/2024
Enfuvirtide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021481.pdf Draft Subcutaneous Injectable 021481 11/19/2024
Eplontersen Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217388.pdf Draft Subcutaneous Solution 217388 11/19/2024
Estrogens, Conjugated https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020216.pdf Draft Topical, Vaginal Cream 020216 11/19/2024
Icatibant Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022150.pdf Draft Subcutaneous Injectable 022150 11/19/2024
Macitentan; Tadalafil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218490.pdf Draft Oral Tablet 218490 11/19/2024
Magnesium sulfate; Polyethylene glycol 3350; Potassium chloride; Sodium chloride; Sodium sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215344.pdf Draft Oral For Solution 215344 11/19/2024
Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021487-ODT.pdf Draft Oral Tablet, Orally Disintegrating 021487 11/19/2024
Mitomycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211728.pdf Draft Pyelocalyceal Powder 211728 11/19/2024
Paclitaxel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216338.pdf Draft Intravenous Powder 216338 11/19/2024
Palovarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215559.pdf Draft Oral Capsule 215559 11/19/2024
Pemetrexed Disodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215179.pdf Draft Intravenous Solution 215179 11/19/2024
Phentolamine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217064.pdf Draft Ophthalmic Solution 217064 11/19/2024
Phytonadione https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_083722.pdf Draft Injection Injectable 083722 11/19/2024
Phytonadione https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_087954.pdf Draft Injection Injectable 087954 087955 11/19/2024
Quizartinib Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216993.pdf Draft Oral Tablet 216993 11/19/2024
Risperidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213586.pdf Draft Subcutaneous Suspension, Extended Release 213586 11/19/2024
Ritlecitinib Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215830.pdf Draft Oral Capsule 215830 11/19/2024
Treprostinil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214324.pdf Draft Inhalation Powder 214324 11/19/2024

Newly Revised Guidances since November 19, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Allopurinol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016084.pdf Draft Oral Tablet 016084 11/19/2024
Azelaic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021470.pdf Draft Topical Gel 021470 11/19/2024
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210251.pdf Draft Oral Tablet 210251 11/19/2024
Budesonide; Formoterol Fumarate Dihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021929.pdf Draft Inhalation Aerosol, Metered 021929 11/19/2024
Enzalutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213674.pdf Draft Oral Tablet 213674 11/19/2024
Ferric Carboxymaltose https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203565.pdf Draft Intravenous Solution 203565 11/19/2024
Ferumoxytol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022180.pdf Draft Intravenous Solution 022180 11/19/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020833.pdf Draft Inhalation Powder 020833 11/19/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021077.pdf Draft Inhalation Powder 021077 11/19/2024
Formoterol Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020831.pdf Draft Inhalation Powder 020831 11/19/2024
Formoterol Fumarate; Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022518.pdf Draft Inhalation Aerosol, Metered 022518 11/19/2024
Labetalol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018687.pdf Draft Oral Tablet 018687 018716 11/19/2024
Lenvatinib Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206947.pdf Draft Oral Capsule 206947 11/19/2024
Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203159.pdf Draft Intrauterine System 021225 203159 11/19/2024
Liraglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022341.pdf Draft Subcutaneous Solution 022341 11/19/2024
Losartan Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020386.pdf Draft Oral Tablet 020386 11/19/2024
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205641.pdf Draft Inhalation Aerosol, Metered 205641 11/19/2024
Nepafenac https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021862.pdf Draft Ophthalmic Suspension/Drops 0.1% 021862 11/19/2024
Nepafenac https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203491.pdf Draft Ophthalmic Suspension/Drops 0.3% 203491 11/19/2024
Nitroglycerin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021359.pdf Draft Intra-anal Ointment 021359 11/19/2024
Olaparib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208558.pdf Draft Oral Tablet 208558 11/19/2024
Phytonadione https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010104.pdf Draft Oral Tablet 010104 11/19/2024
Phytonadione https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011745.pdf Draft Injectable Injection 012223 11/19/2024
Primidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009170.pdf Draft Oral Tablet 009170 11/19/2024
Rasagiline Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021641.pdf Draft Oral Tablet 021641 11/19/2024
Ruxolitinib Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215309.pdf Draft Topical Cream 215309 11/19/2024
Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020692.pdf Draft Inhalation Powder 020692 11/19/2024
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050777.pdf Draft Topical Ointment 050777 11/19/2024
Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021184-Cre-0.05P.pdf Draft Topical Cream 0.05% 021184 11/19/2024
Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021395.pdf Draft Inhalation Powder 021395 11/19/2024
Tramadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020281.pdf Draft Oral Tablet 020281 11/19/2024
Back to Top