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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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
86 record(s) found for 'N'
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Nabilone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nabilone_cap_18677_RC7-08.pdf | Draft | Oral | Capsule | 018677 | 07/01/2009 |
| Nabumetone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nabumetone_tab_75189_RC10-05.pdf | Final | Oral | Tablet | 019583 | 05/12/2008 |
| Nadolol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nadolol_tab_18063_RC5-09.pdf | Final | Oral | Tablet | 018063 | 10/28/2011 |
| Naftifine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naftifine_HCl_cr_19599_RC03-12.pdf | Draft | Topical | Cream 1% | 019599 | 03/28/2012 |
| Naftifine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naftifine_HCl_gel_19356_RC03-12.pdf | Draft | Topical | Gel | 019356 | 03/28/2012 |
| Naftifine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naftifine hydrochloride_topical cream2_RLD 019599_RC01-16.pdf | Draft | Topical | Cream 2% | 019599 | 01/27/2016 |
| Naftifine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naftifine hydrochloride_topical get 2_RLD 204286_RC01-16.pdf | Draft | Topical | Gel | 204286 | 01/27/2016 |
| Naldemedine Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naldemedine tosylate_oral tablet_NDA 208854_RC11-17.pdf | Draft | Oral | Tablet | 208854 | 02/08/2018 |
| Naloxegol Oxalate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naloxegol oxalate_oral tablet_NDA 204760_RV11-17.pdf | Draft | Oral | Tablet | 204760 | 02/08/2018 |
| Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naloxone hydrochloride_ nasal spray_ NDA 208411_RC04-17.pdf | Draft | Nasal | Spray | 208411 | 04/21/2017 |
| Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215457.pdf | Draft | Intramuscular, Subcutaneous | Solution | 215457 | 05/18/2023 |
| Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208969.pdf | Draft | Nasal | Spray, Metered | 208969 | 02/15/2024 |
| Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212045.pdf | Draft | Nasal | Spray | 212045 | 05/19/2022 |
| Naloxone Hydrochloride; Oxycodone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205777.pdf | Draft | Oral | Tablet, Extended Release | 205777 | 11/18/2020 |
| Naltrexone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021897.pdf | Draft | Intramuscular | For Suspension, Extended Release | 021897 | 11/16/2023 |
| Naltrexone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naltrexone_HCl_tab_18932_76264_RC12-09.pdf | Draft | Oral | Tablet | 018932 076264 | 12/01/2009 |
| Naproxen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naproxen_DRtab_20067_RC2-10.pdf | Draft | Oral | Tablet, Delayed Release | 020067 | 02/25/2010 |
| Naproxen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naproxen_Sodium_tab_17581_RC7-08.pdf | Draft | Oral | Tablet | 017581 | 07/01/2008 |
| Naproxen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naproxen Oral Suspension NDA 018965 PSG Page RC May 2019.pdf | Draft | Oral | Suspension | 018965 | 05/15/2019 |
| Naproxen Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naproxen sodium_Oral capsule_021920_RC06-15.pdf | Draft | Oral | Capsule | 021920 | 06/24/2015 |
| Naproxen Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020353.pdf | Draft | Oral | Tablet, Extended Release | 020353 | 02/16/2023 |
| Naproxen Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naproxen_Sodium_tab_18164_RC7-08.pdf | Draft | Oral | Tablet | 018164 | 07/01/2008 |
| Naproxen Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naproxen_Sodium_tab_20204_RC7-08.pdf | Draft | Oral | Tablet | 020204 | 07/01/2008 |
| Naproxen Sodium; Pseudoephedrine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naproxen sodium; Pseudoephedrine HCl_oral ER tablet_NDA 021076_RC11-17.pdf | Draft | Oral | Tablet, Extended Release | 021076 | 02/08/2018 |
| Naproxen Sodium; Sumatriptan Succinate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naproxen_Sodium;_Sumatriptan_Succinate_tab_21926_RC08-10.pdf | Draft | Oral | Tablet | 021926 | 08/30/2010 |
| Naratriptan Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naratriptan_HCl_tab_20763_RC7-08.pdf | Draft | Oral | Tablet | 020763 | 07/01/2008 |
| Nateglinide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nateglinide_tab_21204_RC8-05.pdf | Final | Oral | Tablet | 021204 | 05/12/2008 |
| Nebivolol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nebivolol_HCl_tab_021742_RV12-14.pdf | Draft | Oral | Tablet | 021742 | 12/29/2014 |
| Nebivolol hydrochloride; Valsartan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nebivolol HCl; Valsartan_oral tablet_NDA 206302_RC07-18.pdf | Draft | Oral | Tablet | 206302 | 07/20/2018 |
| Nelfinavir Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nelfinavir Mesylate pwd oral 20778_RC4-06.pdf | Draft | Oral | Suspension | 020778 | 11/01/2007 |
| Nelfinavir Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nelfinavir_Mesylate_tab_20779_RC4-05.pdf | Final | Oral | Tablet | 020779 021503 | 05/01/2008 |
| Nepafenac | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nepafenac_ophthalmic suspension 0.1_RLD 021862_RV12-16.pdf | Draft | Ophthalmic | Suspension/Drops 0.1% | 021862 | 12/22/2016 |
| Nepafenac | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nepafenac_ophthalmic suspension 0.3_RLD 203491_RV12-16.pdf | Draft | Ophthalmic | Suspension/Drops 0.3% | 203491 | 12/22/2016 |
| Neratinib maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Neratinib Maleat Oral Tablets NDA 208051 RC 09-2018.pdf | Draft | Oral | Tablet | 208051 | 09/13/2018 |
| Netarsudil dimesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Netarsudil Dimesylate_Ophthalmic solution drops_NDA 208254_RC Oct 2018.pdf | Draft | Ophthalmic | Solution/Drops | 208254 | 11/28/2018 |
| Netupitant; Palonosetron Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Netupitant and Palonosetron hydrochloride_oral capsule_205718_RC09-15.pdf | Draft | Oral | Capsule | 205718 | 09/18/2015 |
| Nevirapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nevirapine_ER_Tablet_201152_RV07-14.pdf | Draft | Oral | Tablet, Extended Release | 201152 | 07/22/2014 |
| Nevirapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nevirapine_susp_20933_RC8-04.pdf | Final | Oral | Suspension | 020933 | 05/01/2008 |
| Nevirapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nevirapine_oral tablet_RLD 20636_RV03-17.pdf | Draft | Oral | Tablet | 020636 | 05/16/2017 |
| Niacin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Niacin_ER_tab_20381_RC10-09.pdf | Draft | Oral | Tablet, Extended Release | 020381 | 12/23/2009 |
| Nicardipine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nicardipine_HCl_ERcap_20005_RC7-08.pdf | Draft | Oral | Capsule, Extended Release | 020005 | 07/01/2008 |
| Nicardipine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019488.pdf | Draft | Oral | Capsule | 019488 | 11/17/2022 |
| Nicotine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020076.pdf | Draft | Transdermal | Film, Extended Release | 020076 020165 | 11/21/2019 |
| Nicotine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020385.pdf | Draft | Nasal | Spray, Metered | 020385 | 08/02/2022 |
| Nicotine Polacrilex | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nicotine Polacrilex Troche Lozenge NDA 21330 RV 09-2018.pdf | Draft | Oral | Troche/Lozenge | 021330 | 09/13/2018 |
| Nicotine Polacrilex | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nicotine Polacrilex Buccal Chewing Gum NDA 20066 and NDA 18612 RV 09-2018.pdf | Draft | Buccal | Gum, Chewing | 018612 020066 | 09/13/2018 |
| Nicotine Polacrilex | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nicotine Polacrilex Troche Lozenge (Mini) NDA 022360 RV 09-2018.pdf | Draft | Oral | Lozenge | 022360 | 09/13/2018 |
| Nifedipine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nifedipine_ERtab_20198_RC09-12.pdf | Draft | Oral | Tablet, Extended Release | 020198 | 09/01/2012 |
| Nifedipine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nifedipine_cap_18482_RC06-11.pdf | Draft | Oral | Capsule | 018482 | 06/30/2011 |
| Nifedipine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nifedipine_ERtab_19684_RC3-09.pdf | Final | Oral | Tablet, Extended Release | 019684 | 10/28/2011 |
| Nifurtimox | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213464.pdf | Draft | Oral | Tablet | 213464 | 08/02/2022 |
| Nilotinib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022068.pdf | Draft | Oral | Capsule | 022068 | 02/15/2024 |
| Nilutamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nilutamide_tab_20169_RC8-09.pdf | Final | Oral | Tablet | 020169 | 10/28/2011 |
| Nimodipine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nimodipine_oral capsule_NDA 018869_RC07-18.pdf | Draft | Oral | Capsule | 018869 | 07/20/2018 |
| Nintedanib Esylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nintedanib esylate_oral capsule_205832_RC09-15.pdf | Draft | Oral | Capsule | 205832 | 09/18/2015 |
| Niraparib Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Niraparib tosylate_oral capsule_NDA 208447_RC11-17.pdf | Draft | Oral | Capsule | 208447 | 02/08/2018 |
| Niraparib Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214876.pdf | Draft | Oral | Tablet | 214876 | 02/15/2024 |
| Nisoldipine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nisoldipine oral extended release tablet ANDA 079051 RV 09-2018.pdf | Draft | Oral | Tablet, Extended Release | 079051 | 09/13/2018 |
| Nisoldipine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nisoldipine_oral ER tablet_NDA 020356_RV07-18.pdf | Draft | Oral | Tablet, Extended Release | 020356 | 07/20/2018 |
| Nitazoxanide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021497.pdf | Draft | Oral | Tablet | 021497 | 03/24/2021 |
| Nitazoxanide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021498.pdf | Draft | Oral | For Suspension | 021498 | 03/24/2021 |
| Nitisinone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitisinone_oral tablet_NDA 209449_RC07-18.pdf | Draft | Oral | Tablet | 209449 | 07/20/2018 |
| Nitisinone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitisinone_oral capsule_ NDA021232_RC08-17.pdf | Draft | Oral | Capsule | 021232 | 10/19/2017 |
| Nitisinone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitisinone_Oral Suspension_RLD 206356_RC12-16.pdf | Draft | Oral | Suspension | 206356 | 12/22/2016 |
| Nitrofurantoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009175.pdf | Draft | Oral | Suspension | 009175 | 05/19/2021 |
| Nitrofurantoin Macrocrystalline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016620.pdf | Draft | Oral | Capsule | 016620 | 11/21/2019 |
| Nitrofurantoin; Nitrofurantoin Macrocrystalline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020064.pdf | Draft | Oral | Capsule | 020064 | 11/21/2019 |
| Nitroglycerin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitroglycerin_sublingual powder_RLD 208424_RC03-17.pdf | Draft | Sublingual | Powder | 208424 | 05/16/2017 |
| Nitroglycerin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitroglycerin_transdermal ointment_087355_RC06-15.pdf | Draft | Transdermal | Ointment | 087355 | 06/24/2015 |
| Nitroglycerin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitroglycerin_Sublingual_AeroSpray_21780_RV02-12.pdf | Draft | Sublingual | Aerosol, Metered | 021780 | 02/10/2012 |
| Nitroglycerin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitroglycerin_Sublingual_Spray_18750_RV02-12.pdf | Draft | Oral/Sublingual | Spray, Metered | 018705 | 02/10/2012 |
| Nitroglycerin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020145.pdf | Draft | Transdermal | Film, Extended Release | 020145 | 11/21/2019 |
| Nitroglycerin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020144.pdf | Draft | Transdermal | Film, Extended Release | 020144 | 11/21/2019 |
| Nitroglycerin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021359.pdf | Draft | Intra-anal | Ointment | 021359 | 10/21/2022 |
| Nitroglycerin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitroglycerin_sublingual_tab_21134_RC02-11.pdf | Draft | Sublingual | Tablet | 021134 | 02/23/2011 |
| Norethindrone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Norethindrone_tab_(NorQD)_17060_RC10-09.pdf | Draft | Oral | Tablet | 017060 | 10/01/2009 |
| Norethindrone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Norethindrone_tab_16954_RC4-09.pdf | Draft | Oral | Tablet | 016954 | 04/01/2009 |
| Norethindrone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Norethindrone_Acetate_tab_18405_RC3-09.pdf | Draft | Oral | Tablet | 018405 | 03/01/2009 |
| Nortriptyline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nortriptyline HCl_oral capsule_018013_RC09-15.pdf | Draft | Oral | Capsule | 018013 | 09/18/2015 |
| Nusinersen Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209531.pdf | Draft | Intrathecal | Solution | 209531 | 02/17/2022 |
| Nystatin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060578.pdf | Draft | Topical | Powder | 065203 | 08/20/2021 |
| Nystatin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nystatin_susp_50299_RC11-10.pdf | Draft | Oral | Suspension | 062512 | 11/01/2010 |
| Nystatin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060575.pdf | Draft | Topical | Cream | 064022 | 10/21/2022 |
| Nystatin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060571.pdf | Draft | Topical | Ointment | 062124 | 10/21/2022 |
| Nystatin; Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060576.pdf | Draft | Topical | Cream | 062364 | 10/21/2022 |
| Nystatin; Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060572.pdf | Draft | Topical | Ointment | 063305 | 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 |