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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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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: 2378

Product-Specific Guidances for Specific Products Arranged by Active Ingredient

Search by Active Ingredient or by RLD or RS Number

Newly Added Guidances since December 04, 2025

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acoramidis Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216540.pdf Draft Oral Tablet 216540 12/04/2025
Apomorphine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214056.pdf Draft Subcutaneous Solution 214056 12/04/2025
Arimoclomol Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214927.pdf Draft Oral Capsule 214927 12/04/2025
Birch Triterpenes https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215064.pdf Draft Topical Gel 215064 12/04/2025
Bupropion Hydrochloride; Dextromethorphan Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215430.pdf Draft Oral Tablet, Extended Release 215430 12/04/2025
Cabergoline https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020664.pdf Draft Oral Tablet 020664 12/04/2025
Cefepime Hydrochloride; Enmetazobactam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216165.pdf Draft Subcutaneous Powder 216165 12/04/2025
Crinecerfont https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218808.pdf Draft Oral Capsule 218808 12/04/2025
Crinecerfont https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218820.pdf Draft Oral Solution 218820 12/04/2025
Desmopressin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017922.pdf Draft Nasal Spray, Metered 017922 12/04/2025
Deutivacaftor; Tezacaftor; Vanzacaftor Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218730.pdf Draft Oral Tablet 218730 12/04/2025
Docetaxel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218711.pdf Draft Subcutaneous Solution 218711 12/04/2025
Elafibranor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218860.pdf Draft Oral Tablet 218860 12/04/2025
Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217660.pdf Draft Oral Granules 217660 12/04/2025
Ensartinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218171.pdf Draft Oral Capsule 218171 12/04/2025
Escitalopram Oxalate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021323-ODT.pdf Draft Oral Tablet 021323 12/04/2025
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208564.pdf Draft Vaginal Insert 208564 12/08/2025
Estradiol; Norethindrone Acetate; Relugolix https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214846.pdf Draft Oral Tablet 214846 12/04/2025
Estradiol; Progesterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210132.pdf Draft Oral Capsule 210132 12/04/2025
Fenfluramine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212102.pdf Draft Oral Solution 212102 12/04/2025
Flurpiridaz F-18 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215168.pdf Draft Intravenous Solution 215168 12/04/2025
Gepotidacin Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218230.pdf Draft Oral Tablet 218230 12/04/2025
Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_219141.pdf Draft Oral For Suspension 219141 12/04/2025
Hydroxychloroquine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214581.pdf Draft Oral Tablet 214581 12/04/2025
Iomeprol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216016.pdf Draft Intra-arterial Solution 216016 12/04/2025
Iomeprol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216017.pdf Draft Intravenous Solution 216017 12/04/2025
Isotretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211913.pdf Draft Oral Capsule 211913 12/04/2025
Ketorolac Tromethamine; Phenylephrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205388.pdf Draft Irrigation Solution 205388 12/04/2025
Levacetylleucine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_219132.pdf Draft Oral For Suspension 219132 12/04/2025
Omeprazole; Sodium Bicarbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213593.pdf Draft Oral For Suspension 213593 12/04/2025
Pegulicianine Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214511.pdf Draft Intravenous Powder 214511 12/04/2025
Pivmecillinam Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216483.pdf Draft Oral Tablet 216483 12/04/2025
Potassium Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019561.pdf Draft Oral For Suspension, Extended Release 019561 12/04/2025
Prednisolone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017469.pdf Draft Ophthalmic Suspension/Drops 017469 12/04/2025
Primidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009170-ODT.pdf Draft Oral Tablet, Orally Disintegrating 009170 12/04/2025
Pyridostigmine Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_015193.pdf Draft Oral Syrup 015193 12/04/2025
Pyridostigmine Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217604.pdf Draft Oral Tablet, Extended Release 217604 12/04/2025
Revumenib Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218944.pdf Draft Oral Tablet 218944 12/04/2025
Roflumilast https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217242.pdf Draft Topical Foam 217242 12/04/2025
Selpercatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218160.pdf Draft Oral Tablet 218160 12/04/2025
Suzetrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_219209.pdf Draft Oral Tablet 219209 12/04/2025
Talazoparib Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217439.pdf Draft Oral Capsule 217439 12/04/2025
Tenapanor Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213931.pdf Draft Oral Tablet 213931 12/04/2025
Testosterone Undecanoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208088.pdf Draft Oral Capsule 208088 12/04/2025
Treosulfan https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214759.pdf Draft Intravenous Powder 214759 12/04/2025

Newly Revised Guidances since December 04, 2025

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Baclofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017851.pdf Draft Oral Tablet 017851 12/04/2025
Baricitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207924.pdf Draft Oral Tablet 207924 12/04/2025
Brigatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208772.pdf Draft Oral Tablet 208772 12/04/2025
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215935-REV-2025-12.pdf Draft Oral Capsule, Delayed Release 215935 12/04/2025
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020929.pdf Draft Inhalation Suspension 020929 12/04/2025
Calcitonin Salmon https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017808.pdf Draft Injection Injectable 017808 017769 12/04/2025
Carbinoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022556.pdf Draft Oral Suspension, Extended Release 022556 12/04/2025
Carvedilol Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022012.pdf Draft Oral Capsule, Extended Release 022012 12/04/2025
Cenobamate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212839.pdf Draft Oral Tablet 212839 12/04/2025
Dabrafenib Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202806.pdf Draft Oral Capsule 202806 12/04/2025
Dasiglucagon Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214231.pdf Draft Subcutaneous Solution 214231 12/04/2025
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020062.pdf Draft Oral Capsule, Extended Release 020062 12/04/2025
Epinephrine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019430.pdf Draft Intramuscular, Subcutaneous Injectable 019430 12/04/2025
Epinephrine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214697.pdf Draft Nasal Spray 214697 12/04/2025
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020908.pdf Draft Vaginal Tablet 020908 12/08/2025
Etodolac https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018922-Tab.pdf Draft Oral Tablet 018922 12/04/2025
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020121.pdf Draft Nasal Spray, Metered 020121 12/04/2025
Glucagon https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212097.pdf Draft Intravenous, Subcutaneous Solution 212097 12/04/2025
Glucagon https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210134.pdf Draft Nasal Powder 210134 12/04/2025
Hydrochlorothiazide; Metoprolol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018303.pdf Draft Oral Tablet 018303 12/04/2025
Ixazomib Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208462.pdf Draft Oral Capsule 208462 12/04/2025
Liraglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022341.pdf Draft Subcutaneous Solution 022341 12/04/2025
Liraglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206321.pdf Draft Subcutaneous Solution 206321 12/04/2025
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022000.pdf Draft Oral Tablet, Delayed Release 022000 12/04/2025
Omeprazole; Sodium Bicarbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021636.pdf Draft Oral Suspension 021636 12/04/2025
Pegcetacoplan https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215014.pdf Draft Subcutaneous Solution 215014 12/04/2025
Pegcetacoplan https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217171.pdf Draft Intravitreal Solution 217171 12/04/2025
Posaconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214770.pdf Draft Oral For Suspension, Delayed Release 214770 12/04/2025
Pyridostigmine Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009829.pdf Draft Oral Tablet 009829 12/04/2025
Semaglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215256.pdf Draft Subcutaneous Solution 215256 12/04/2025
Sunitinib Malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021938.pdf Draft Oral Capsule 021938 12/04/2025
Tapinarof https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215272.pdf Draft Topical Cream 215272 12/04/2025
Teriparatide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021318.pdf Draft Subcutaneous Solution 021318 218771 12/04/2025
Tirzepatide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215866.pdf Draft Subcutaneous Solution 215866 12/04/2025
Treprostinil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214324.pdf Draft Inhalation Powder 214324 12/04/2025
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017340.pdf Draft Topical Cream 017340 019049 017522 12/04/2025
Trospium Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022103.pdf Draft Oral Capsule, Extended Release 022103 12/04/2025
Vosoritide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214938.pdf Draft Subcutaneous Powder 214938 12/04/2025
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