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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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.
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.
1
2
Total number of currently published PSGs: 2187
78 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 Pellets.pdf | Draft | Oral | Capsule, Pellets | 215498 | 05/18/2023 |
| Odevixibat | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215498-Cap.pdf | Draft | Oral | Capsule | 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 | 08/20/2021 |
| Olodaterol Hydrochloride; Tiotropium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206756.pdf | Draft | Inhalation | Spray, Metered | 206756 | 07/27/2021 |
| 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_209816.pdf | Draft | Oral | Tablet | 209816 | 11/21/2019 |
| Omadacycline Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209817.pdf | Draft | Intravenous | Powder | 209817 | 11/21/2019 |
| 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/PSG_021087.pdf | Draft | Oral | Capsule | 021087 | 05/19/2022 |
| 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 |
| 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 |
| 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/Oxcarbazepine_tab_21014_RC5-05.pdf | Final | Oral | Tablet | 021014 | 05/01/2008 |
| Oxcarbazepine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxcarbazepine_ER_Tablets_202810_RC07-14.pdf | Draft | Oral | Tablet, Extended Release | 202810 | 07/22/2014 |
| 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_021351.pdf | Draft | Transdermal | Film, Extended Release | 021351 | 11/21/2019 |
| 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/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_ERtabs_ 20897_RV11-13.pdf | Draft | Oral | Tablet, Extended Release | 020897 | 11/05/2013 |
| 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 |
| 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/Oxymorphone_HCl_ERcap_21610_RC11-07.pdf | Draft | Oral | Tablet, Extended Release | 021610 | 02/25/2010 |
| Oxymorphone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxymorphone HCl_oral ER tablet_RLD 201655_RC09-16.pdf | Draft | Oral | Tablet, Extended Release | 201655 | 10/04/2016 |
| 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 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 |