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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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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: 2223

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


79 record(s) found for 'O'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Obeticholic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Obeticholic acid_oral tablet_NDA 207999_RC05-17.pdf Draft Oral Tablet 207999 07/13/2017
Octreotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208232.pdf Draft Oral Capsule, Delayed Release 208232 03/24/2021
Octreotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Octreotide acetate_inj_21008_RV02-14.pdf Draft Injection Injectable 021008 02/01/2014
Octreotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213224.pdf Draft Subcutaneous Solution 213224 03/24/2021
Odevixibat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215498-Cap.pdf Draft Oral Capsule 215498 05/18/2023
Odevixibat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215498-Cap Pellets.pdf Draft Oral Capsule, Pellets 215498 05/18/2023
Ofloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ofloxacin_ophthalmic solution drops_NDA 019921_RV08-17.pdf Draft Ophthalmic Solution/Drops 019921 10/19/2017
Olanzapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olanzapine_tab_20592_RC8-08.pdf Draft Oral Tablet 020592 08/01/2008
Olanzapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021086.pdf Draft Oral Tablet, Orally Disintegrating 021086 11/08/2021
Olanzapine Pamoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olanzapine_Intramuscular ER suspension_RLD22173_RC01-16.pdf Draft Intramuscular Suspension, Extended Release 022173 01/27/2016
Olanzapine; Samidorphan L-Malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213378.pdf Draft Oral Tablet 213378 02/16/2023
Olaparib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olaparib Oral Tablet NDA 208558 RC 09-2018.pdf Draft Oral Tablet 208558 09/13/2018
Olaparib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olaparib_oral capsule_NDA 206162_RC08-17.pdf Draft Oral Capsule 206162 10/19/2017
Oliceridine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210730.pdf Draft Intravenous Solution 210730 05/19/2022
Olive Oil; Soybean Oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olive oil; Soybean Oil injectable injection RLD 204508 RC 09-2018.pdf Draft Injection Injectable 204508 09/13/2018
Olmesartan Medoxomil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olmesartan_Medoxomil_tab_21286_RC5-06.pdf Final Oral Tablet 021286 05/12/2008
Olodaterol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf Draft Inhalation Spray, Metered 203108 08/22/2024
Olodaterol Hydrochloride; Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206756.pdf Draft Inhalation Spray, Metered 206756 08/22/2024
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021861.pdf Draft Nasal Spray, Metered 021861 08/02/2022
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olopatadine HCl_ophthalmic solution_NDA 021545_RV08-17.pdf Draft Ophthalmic Solution/Drops 0.2% 021545 10/19/2017
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olopatadine hydrochloride_ophthalmic solution_NDA 020688_RV08-17.pdf Draft Ophthalmic Solution/Drops 0.1% 020688 10/19/2017
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olopatadine hydrochloride_ophthalmic solution_NDA 206276_RC11-17.pdf Draft Ophthalmic Solution/Drops 206276 02/08/2018
Olsalazine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019715.pdf Draft Oral Capsule 019715 03/02/2020
Olutasidenib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215814.pdf Draft Oral Capsule 215814 02/15/2024
Omadacycline Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209817.pdf Draft Intravenous Powder 209817 11/21/2019
Omadacycline Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209816.pdf Draft Oral Tablet 209816 11/21/2019
Omaveloxolone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216718.pdf Draft Oral Capsule 216718 05/16/2024
Ombitasvir; Paritaprevir; Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ombitasvir_Paritaprevir_Ritonavir_oral tablet_RLD 207931_RC06-16.pdf Draft Oral Tablet 207931 06/16/2016
Omega 3 Acid Ethyl Esters https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021654.pdf Draft Oral Capsule 021654 08/28/2020
Omega3 Acid Ethyl Esters Type A https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omega-3-Acid Ethyl Esters_oral capsule_RLD 204977_RC12-16.pdf Draft Oral Capsule 204977 12/22/2016
Omega3 Carboxylic Acids https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omega-3 Carboxylic Acids_oral capsule_RLD 205060_RV12-16.pdf Draft Oral Capsule 205060 12/22/2016
Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_DRcap_19810_RC5-06.pdf Draft Oral Capsule, Delayed Release 019810 11/26/2010
Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_DRtab_022032_RC09-12.pdf Draft Oral Tablet, Delayed Release 022032 09/19/2012
Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_orally disintegrating DR tablet_NDA 209400_RC07-18.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 209400 07/20/2018
Omeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole magnesium oral delayed release suspension NDA 022056 PSG Page RC May 2019.pdf Draft Oral For Suspension, Delayed Release 022056 05/15/2019
Omeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_Magnesium_DRtabOTC_21229_RC4-06.pdf Final Oral Tablet, Delayed Release 021229 05/12/2008
Omeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_078878.pdf Draft Oral Capsule, Delayed Release 078878 11/17/2022
Omeprazole; Sodium Bicarbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole;_Sodium Bicarbonate_cap_21849_RC7-08.pdf Draft Oral Capsule 021849 07/01/2008
Omeprazole; Sodium Bicarbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_susp_21636_R5-05.pdf Draft Oral Suspension 021636 07/01/2009
Omeprazole; Sodium Bicarbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_Sodium bicarbonate_Oral suspension_022283_RC06-15.pdf Draft Oral Suspension, Powder 022283 06/24/2015
Omidenepag Isopropyl https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215092.pdf Draft Ophthalmic Solution 215092 11/16/2023
Ondansetron https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ondansetron_oral_film_22524_RC03-12.pdf Draft Oral Film 022524 03/28/2012
Ondansetron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020781.pdf Draft Oral Tablet, Orally Disintegrating 020781 11/08/2021
Ondansetron Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ondansetron_tab_20103_RC5-03.pdf Final Oral Tablet 020103 05/12/2008
Opicapone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212489.pdf Draft Oral Capsule 212489 11/08/2021
Orlistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020766.pdf Draft Oral Capsule 020766 021887 08/20/2021
Orphenadrine Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Orphenadrine_ Citrate_ERtabs_40327_RC04-10.pdf Draft Oral Tablet, Extended Release 012157 04/20/2010
Oseltamivir Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oseltamivir_phosphate_oral susp_21246_RV03-15.pdf Draft Oral Suspension 021246 03/06/2015
Oseltamivir Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021087.pdf Draft Oral Capsule 021087 05/19/2022
Osilodrostat Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212801.pdf Draft Oral Tablet 212801 08/20/2021
Osimertinib Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208065.pdf Draft Oral Tablet 208065 02/17/2022
Ospemifene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ospemifene_tab_203505_RC07-14.pdf Draft Oral Tablet 203505 07/22/2014
Oteseconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215888.pdf Draft Oral Capsule 215888 08/21/2023
Oxaprozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxaprozin_oral tablet_RLD 18841_RC04-16.pdf Draft Oral Tablet 018841 04/14/2016
Oxazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_015539-Cap.pdf Draft Oral Capsule 015539 072253 05/16/2024
Oxcarbazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxcarbazepine_tab_21014_RC5-05.pdf Final Oral Tablet 021014 05/01/2008
Oxcarbazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxcarbazepine_susp_21285_RC11-03.pdf Final Oral Suspension 021285 05/12/2008
Oxcarbazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202810.pdf Draft Oral Tablet, Extended Release 202810 08/22/2024
Oxiconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxiconazole Nitrate Lotion NDA 020209 RV Feb 2019.pdf Draft Topical Lotion 020209 02/22/2019
Oxiconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxiconazole Nitrate Cream NDA 019828 RV Feb 2019.pdf Draft Topical Cream 019828 02/22/2019
Oxybutynin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202211.pdf Draft Transdermal Film, Extended Release 202211 11/21/2019
Oxybutynin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021351.pdf Draft Transdermal Film, Extended Release 021351 11/21/2019
Oxybutynin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxybutynin_ Transdermal metered gel_202513_RC06-15.pdf Draft Transdermal Gel, Metered 202513 06/24/2015
Oxybutynin Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxybutynin chloride_transdermal gel 10_RLD 22204_RC04-16.pdf Draft Transdermal Gel 022204 04/14/2016
Oxybutynin Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxybutynin Chloride_Oral tab_075079_RC03-15.pdf Draft Oral Tablet 075079 03/06/2015
Oxybutynin Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxybutynin_ERtabs_ 20897_RV11-13.pdf Draft Oral Tablet, Extended Release 020897 11/05/2013
Oxycodone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208090.pdf Draft Oral Capsule, Extended Release 208090 11/17/2022
Oxycodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone hydrochloride_oral capsule_200534_RC06-15.pdf Draft Oral Capsule 200534 06/24/2015
Oxycodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone hydrochloride_oral ER tablet_NDA 022272_RV07-18.pdf Draft Oral Tablet, Extended Release 022272 07/20/2018
Oxycodone hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone hydrochloride oral tablet NDA 209777 RC 09-2018.pdf Draft Oral Tablet 209777 09/13/2018
Oxycodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone_tab_21011_12-09.pdf Draft Oral Tablet 021011 12/17/2009
Oxymetazoline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212520.pdf Draft Ophthalmic Solution/Drops 212520 04/02/2024
Oxymetazoline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208552.pdf Draft Topical Cream 208552 10/21/2022
Oxymetazoline Hydrochloride; Tetracaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208032.pdf Draft Nasal Spray, Metered 208032 08/02/2022
Oxymetholone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxymetholone_tabs_16848_RC2-11.pdf Draft Oral Tablet 016848 02/23/2011
Oxymorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxymorphone_HCl_tab_21611_RC1-08.pdf Draft Oral Tablet 021611 02/23/2008
Oxymorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021610.pdf Draft Oral Tablet, Extended Release 021610 08/22/2024
Ozanimod Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209899.pdf Draft Oral Capsule 209899 08/20/2021
Ozenoxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208945.pdf Draft Topical Cream 208945 10/21/2022

Newly Added Guidances since August 22, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Air Polymer-Type A https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212279.pdf Draft Intrauterine Foam 212279 08/22/2024
Fezolinetant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216578.pdf Draft Oral Tablet 216578 08/22/2024
Heparin Sodium; Taurolidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214520.pdf Draft N/A Solution 214520 08/22/2024
Leniolisib Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217759.pdf Draft Oral Tablet 217759 08/22/2024
Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217722.pdf Draft Nasal Spray, Metered 217722 08/22/2024
Nedosiran Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215842.pdf Draft Injection Solution 215842 08/22/2024
Nirmatrelvir; Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217188.pdf Draft Oral Tablet; Tablet 217188 08/22/2024
Pegcetacoplan https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217171.pdf Draft Intravitreal Solution 217171 08/22/2024
Risperidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212849.pdf Draft Intramuscular For Suspension, Extended Release 212849 08/22/2024
Sotagliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216203.pdf Draft Oral Tablet 216203 08/22/2024
Tafluprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202514.pdf Draft Ophthalmic Solution, Drops 202514 08/22/2024
Teriparatide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021318.pdf Draft Subcutaneous Solution 021318 08/22/2024
Tofersen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215887.pdf Draft Intrathecal Solution 215887 08/22/2024
Trofinetide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217026.pdf Draft Oral Solution 217026 08/22/2024

Newly Revised Guidances since August 22, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020503.pdf Draft Inhalation Aerosol, Metered 020503 020983 021457 08/22/2024
Albuterol Sulfate; Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf Draft Inhalation Spray, Metered 021747 08/22/2024
Apalutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210951.pdf Draft Oral Tablet 210951 08/22/2024
Azelaic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020428.pdf Draft Topical Cream 020428 08/22/2024
Bempedoic Acid; Ezetimibe https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211617.pdf Draft Oral Tablet 211617 08/22/2024
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021949.pdf Draft Inhalation Powder, Metered 021949 08/22/2024
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020358.pdf Draft Oral Tablet, Extended Release 020358 020711 08/22/2024
Carvedilol Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022012.pdf Draft Oral Capsule, Extended Release 022012 08/22/2024
Ciprofloxacin Hydrochloride; Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020805.pdf Draft Otic Suspension/Drops 020805 08/22/2024
Ciprofloxacin; Dexamethasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021537.pdf Draft Otic Suspension/Drops 021537 08/22/2024
Cladribine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022561.pdf Draft Oral Tablet 022561 08/22/2024
Dalfampridine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022250.pdf Draft Oral Tablet, Extended Release 022250 08/22/2024
Dapagliflozin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205649.pdf Draft Oral Tablet, Extended Release 205649 08/22/2024
Donepezil Hydrochloride; Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206439.pdf Draft Oral Capsule, Extended Release 206439 08/22/2024
Fentanyl Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022569.pdf Draft Nasal Spray, Metered 022569 08/22/2024
Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 08/22/2024
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf Draft Inhalation Powder 209482 08/22/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021433.pdf Draft Inhalation Aerosol, Metered 021433 08/22/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020833.pdf Draft Inhalation Powder 020833 08/22/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208798.pdf Draft Inhalation Powder 208798 08/22/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf Draft Inhalation Powder 208799 08/22/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021254.pdf Draft Inhalation Aerosol, Metered 021254 08/22/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021077.pdf Draft Inhalation Powder 021077 08/22/2024
Halobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019968.pdf Draft Topical Ointment 019968 08/22/2024
Hydrochlorothiazide; Metoprolol Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021956.pdf Draft Oral Tablet, Extended Release 021956 08/22/2024
Hydromorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021217.pdf Draft Oral Tablet, Extended Release 021217 08/22/2024
Ibrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210563.pdf Draft Oral Tablet 210563 08/22/2024
Levalbuterol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021730.pdf Draft Inhalation Aerosol, Metered 021730 08/22/2024
Levomilnacipran Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204168.pdf Draft Oral Capsule, Extended Release 204168 08/22/2024
Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022525.pdf Draft Oral Capsule, Extended Release 022525 08/22/2024
Metformin Hydrochloride; Sitagliptin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202270.pdf Draft Oral Tablet, Extended Release 202270 08/22/2024
Metformin Hydrochloride;Saxagliptin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200678.pdf Draft Oral Tablet, Extended Release 200678 08/22/2024
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021067.pdf Draft Inhalation Powder 021067 08/22/2024
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019516.pdf Draft Oral Tablet, Extended Release 019516 08/22/2024
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021260.pdf Draft Oral Capsule, Extended Release 079040 08/22/2024
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020616.pdf Draft Oral Capsule, Extended Release 020616 08/22/2024
Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208411.pdf Draft Nasal Spray, Metered 208411 08/22/2024
Olodaterol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf Draft Inhalation Spray, Metered 203108 08/22/2024
Olodaterol Hydrochloride; Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206756.pdf Draft Inhalation Spray, Metered 206756 08/22/2024
Oxcarbazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202810.pdf Draft Oral Tablet, Extended Release 202810 08/22/2024
Oxymorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021610.pdf Draft Oral Tablet, Extended Release 021610 08/22/2024
Phentermine Hydrochloride;Topiramate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022580.pdf Draft Oral Capsule, Extended Release 022580 08/22/2024
Posaconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205053.pdf Draft Oral Tablet, Delayed Release 205053 08/22/2024
Pramipexole Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022421.pdf Draft Oral Tablet, Extended Release 022421 08/22/2024
Progesterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022057.pdf Draft Vaginal Insert 022057 08/22/2024
Promethazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010926.pdf Draft Rectal Suppository 010926 08/22/2024
Quetiapine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022047.pdf Draft Oral Tablet, Extended Release 022047 08/22/2024
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206406.pdf Draft Oral Tablet, Extended Release 206406 08/22/2024
Tapentadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200533.pdf Draft Oral Tablet, Extended Release 200533 08/22/2024
Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021936.pdf Draft Inhalation Spray, Metered 021936 08/22/2024
Tramadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021692.pdf Draft Oral Tablet, Extended Release 021692 08/22/2024
Trospium Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022103.pdf Draft Oral Capsule, Extended Release 022103 08/22/2024
Venlafaxine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022104.pdf Draft Oral Tablet, Extended Release 022104 08/22/2024
Verteporfin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021119.pdf Draft Injection Injectable 021119 08/22/2024
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