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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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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: 2187

Product-Specific Guidances for Specific Products Arranged by Active Ingredient

Search by Active Ingredient or by RLD or RS Number

Newly Added Guidances since February 15, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215413.pdf Draft Oral Tablet, For Suspension 215413 02/15/2024
Adagrasib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216340.pdf Draft Oral Tablet 216340 02/15/2024
Amoxicillin; Clarithromycin; Vonoprazan Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215152.pdf Draft Oral Capsule, Tablet, Tablet 215152 02/15/2024
Amoxicillin; Vonoprazan Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215153.pdf Draft Oral Capsule, Tablet 215153 02/15/2024
Baclofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215422.pdf Draft Oral Granules 215422 02/15/2024
Budesonide; Formoterol Fumarate; Glycopyrrolate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212122.pdf Draft Inhalation Aerosol, Metered 212122 02/15/2024
Caffeine; Ergotamine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_086557.pdf Draft Rectal Suppository 086557 009000 02/15/2024
Durlobactam Sodium; Durlobactam Sodium; Sulbactam Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216974.pdf Draft Intravenous Powder 216974 02/15/2024
Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213388.pdf Draft Oral Capsule 213388 02/15/2024
Ferric Derisomaltose https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208171.pdf Draft Intravenous Solution 208171 02/15/2024
Finasteride; Tadalafil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215423.pdf Draft Oral Capsule 215423 02/15/2024
Flotufolastat F-18 Gallium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216023.pdf Draft Intravenous Solution 216023 02/15/2024
Formoterol Fumarate; Glycopyrrolate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208294.pdf Draft Inhalation Aerosol, Metered 208294 02/15/2024
Lenacapavir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215974.pdf Draft Oral Tablet 215974 02/15/2024
Lenacapavir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215973.pdf Draft Subcutaneous Solution 215973 02/15/2024
Mannitol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022368.pdf Draft Inhalation Powder 022368 02/15/2024
Mannitol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202049.pdf Draft Inhalation Powder 202049 02/15/2024
Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208969.pdf Draft Nasal Spray, Metered 208969 02/15/2024
Niraparib Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214876.pdf Draft Oral Tablet 214876 02/15/2024
Olutasidenib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215814.pdf Draft Oral Capsule 215814 02/15/2024
Oxymetazoline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212520.pdf Draft Ophthalmic Solution/Drops 212520 04/02/2024
Rivaroxaban https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215859.pdf Draft Oral For Suspension 215859 02/15/2024
Sertraline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215133.pdf Draft Oral Capsule 215133 02/15/2024
Sodium Phenylbutyrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214860.pdf Draft Oral For Suspension 214860 02/15/2024
Sodium Phenylbutyrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216513.pdf Draft Oral Pellets 216513 02/15/2024
Sodium Phenylbutyrate; Taurursodiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216660.pdf Draft Oral For Suspension 216660 02/15/2024
Terlipressin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022231.pdf Draft Intravenous Powder 022231 02/15/2024
Testosterone Undecanoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213953.pdf Draft Oral Capsule 213953 02/15/2024
Xenon Xe-129 Hyperpolarized https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214375.pdf Draft Inhalation Gas 214375 02/15/2024
Zanamivir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021036.pdf Draft Inhalation Powder 021036 02/15/2024

Newly Revised Guidances since February 15, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Aclidinium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202450.pdf Draft Inhalation Powder, Metered 202450 02/15/2024
Aclidinium Bromide; Formoterol Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210595.pdf Draft Inhalation Powder, Metered 210595 02/15/2024
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205636.pdf Draft Inhalation Powder, Metered 205636 02/15/2024
Aprepitant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209296.pdf Draft Intravenous Emulsion 209296 216457 02/15/2024
Betamethasone Dipropionate; Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020010.pdf Draft Topical Lotion 020010 076493 02/15/2024
Betamethasone Dipropionate; Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018827.pdf Draft Topical Cream 018827 075673 02/15/2024
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021949.pdf Draft Inhalation Powder, Metered 021949 02/15/2024
Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207154.pdf Draft Topical Gel 207154 02/15/2024
Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021794.pdf Draft Topical Gel 021794 02/15/2024
Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050023.pdf Draft Ophthalmic Suspension/Drops 050023 02/15/2024
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050616.pdf Draft Ophthalmic Ointment 050616 02/15/2024
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050592.pdf Draft Ophthalmic Suspension/Drops 050592 02/15/2024
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050818.pdf Draft Ophthalmic Suspension/Drops 050818 02/15/2024
Diazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211635.pdf Draft Nasal Spray 211635 02/15/2024
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022036.pdf Draft Oral Tablet 022036 02/15/2024
Ferric Carboxymaltose https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203565.pdf Draft Intravenous Solution 203565 02/15/2024
Fluorometholone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016851.pdf Draft Ophthalmic Suspension/Drops 016851 02/15/2024
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf Draft Inhalation Powder 209482 02/15/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208798.pdf Draft Inhalation Powder 208798 02/15/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020833.pdf Draft Inhalation Powder 020833 02/15/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021077.pdf Draft Inhalation Powder 021077 02/15/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf Draft Inhalation Powder 208799 02/15/2024
Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060613.pdf Draft Otic Suspension/Drops 060613 02/15/2024
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf Draft Ophthalmic Suspension/Drops 020583 02/15/2024
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200738.pdf Draft Ophthalmic Ointment 200738 02/15/2024
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020803.pdf Draft Ophthalmic Suspension/Drops 020803 02/15/2024
Loteprednol Etabonate; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050804.pdf Draft Ophthalmic Suspension/Drops 050804 02/15/2024
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021067.pdf Draft Inhalation Powder 021067 02/15/2024
Nilotinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022068.pdf Draft Oral Capsule 022068 02/15/2024
Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020692.pdf Draft Inhalation Powder 020692 02/15/2024
Umeclidinium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205382.pdf Draft Inhalation Powder 205382 02/15/2024
Umeclidinium Bromide; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203975.pdf Draft Inhalation Powder 203975 02/15/2024
Vandetanib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022405.pdf Draft Oral Tablet 022405 02/15/2024
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