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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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.
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2
Total number of currently published PSGs: 2187
128 record(s) found for 'P'
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Paclitaxel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021660.pdf | Draft | IV Infusion | For Suspension | 021660 | 08/20/2021 |
| Pacritinib Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208712.pdf | Draft | Oral | Capsule | 208712 | 08/21/2023 |
| Pafolacianine Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214907.pdf | Draft | Intravenous | Solution | 214907 | 08/02/2022 |
| Palbociclib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Palbociclib_oral capsule_RLD 207103_RC04-16.pdf | Draft | Oral | Capsule | 207103 | 04/14/2016 |
| Palbociclib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212436.pdf | Draft | Oral | Tablet | 212436 | 05/19/2022 |
| Paliperidone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Paliperidone_oral_ERtab_021999_RV03-15.pdf | Draft | Oral | Tablet, Extended Release | 021999 | 03/06/2015 |
| Paliperidone Palmitate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207946.pdf | Draft | Intramuscular | Suspension, Extended Release | 207946 | 08/20/2021 |
| Paliperidone Palmitate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022264.pdf | Draft | Intramuscular | Suspension, Extended Release | 022264 | 05/18/2023 |
| Palonosetron Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Palonosetron_HCl_cap_22233_RC12-10.pdf | Draft | Oral | Capsule | 022233 | 12/23/2010 |
| Panobinostat Lactate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Panobinosat lactate_oral capsule_RLD 205353_RC12-16.pdf | Draft | Oral | Capsule | 205353 | 12/22/2016 |
| Pantoprazole Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pantoprazole sodium_oral DR suspension_NDA 022020_RV11-17.pdf | Draft | Oral | Powder For Suspension, Delayed Release | 022020 | 02/08/2018 |
| Pantoprazole Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pantoprazole_Sodium_DRtab_20987_RC7-06.pdf | Final | Oral | Tablet, Delayed Release | 020987 | 05/12/2008 |
| Paricalcitol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Paricalcitol_cap_21606_RC11-07.pdf | Draft | Oral | Capsule | 021606 | 11/01/2007 |
| Paroxetine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Paroxetine_HCl_tab_20031_RC8-08.pdf | Draft | Oral | Tablet | 020031 | 08/01/2008 |
| Paroxetine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Paroxetine_oral ER tablet_RLD 020936_RV06-16.pdf | Draft | Oral | Tablet, Extended Release | 020936 | 06/16/2016 |
| Paroxetine mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Paroxetine Mesylate Oral Tablets NDA NDA 021299 RC Feb 2019.pdf | Draft | Oral | Tablet | 021299 | 02/22/2019 |
| Paroxetine Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Paroxetine mesylate cap 204516_RC07-14.pdf | Draft | Oral | Capsule | 204516 | 07/22/2014 |
| Patisiran Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210922.pdf | Draft | Intravenous | Solution | 210922 | 11/17/2022 |
| Pazopanib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022465.pdf | Draft | Oral | Tablet | 022465 | 03/24/2021 |
| Pemigatinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213736.pdf | Draft | Oral | Tablet | 213736 | 11/08/2021 |
| Penbutolol Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Penbutolol_tab_18976_RC09-10.pdf | Draft | Oral | Tablet | 018976 | 09/30/2010 |
| Penciclovir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020629.pdf | Draft | Topical | Cream | 020629 | 10/21/2022 |
| Penicillamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Penicillamine_Oral Tablet_NDA 19854_RC Oct 2018.pdf | Draft | Oral | Tablet | 019854 | 11/28/2018 |
| Penicillamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Penicillamine_cap_19853_RC8-08.pdf | Draft | Oral | Capsule | 019853 | 08/01/2008 |
| Penicillin G Benzathine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050141.pdf | Draft | Injection | Injectable | 050141 | 03/24/2021 |
| Penicillin V Potassium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Penicillin_V_Potassium_tab_64071_RC06-11.pdf | Draft | Oral | Tablet | 064071 | 06/01/2011 |
| Pentosan Polysulfate Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020193.pdf | Draft | Oral | Capsule | 020193 | 05/19/2021 |
| Pentoxifylline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018631.pdf | Draft | Oral | Tablet, Extended Release | 018631 | 05/18/2023 |
| Perampanel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Perampanel_oral suspension_RLD 208277_RC12-16.pdf | Draft | Oral | Suspension | 208277 | 12/22/2016 |
| Perampanel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Perampanel_tab_202834_RC02-14.pdf | Draft | Oral | Tablet | 202834 | 04/01/2014 |
| Perflutren | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Perflutren Liposomal Injection RLD 021064 RC 09-2018 .pdf | Draft | Intravenous | Injectable | 021064 | 09/13/2018 |
| Perindopril Erbumine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Perindopril_Erbumine_tab_20184_RC5-05.pdf | Final | Oral | Tablet | 020184 | 05/12/2008 |
| Permethrin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Permethrin_topical cream_RLD 019855_RC08-17.pdf | Draft | Topical | Cream | 019855 | 10/19/2017 |
| Perphenazine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Perphenazine_tab_89686_89685_89684_89683_RC2-10.pdf | Draft | Oral | Tablet | 010775 | 02/25/2010 |
| Pexidartinib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211810.pdf | Draft | Oral | Capsule | 211810 | 05/19/2021 |
| Phendimetrazine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phendimetrazine_tartrate_tab_85272_RC8-09.pdf | Final | Oral | Tablet | 085272 | 10/28/2011 |
| Phendimetrazine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phendimetrazine_tartrate_ERcap_18074_RC8-09.pdf | Final | Oral | Capsule, Extended Release | 018074 | 10/28/2011 |
| Phenelzine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phenelzine_Sulfate_tab_11909_RC04-10.pdf | Draft | Oral | Tablet | 011909 | 04/20/2010 |
| Phenoxybenzamine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phenoxybenzamine_HCl_cap_08708_RV12-12.pdf | Draft | Oral | Capsule | 008708 | 12/14/2012 |
| Phentermine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phentermine_HCl_cap_88023_87190_RC5-09.pdf | Final | Oral | Capsule | 087190 088023 | 10/28/2011 |
| Phentermine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phentermine_HCl_tab_85128_88605_RC5-09.pdf | Final | Oral | Tablet | 085128 088605 | 10/28/2011 |
| Phentermine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phentermine_HCl_ODT_202088_RC11-13.pdf | Draft | Oral | Tablet, Orally Disintegrating | 202088 | 11/05/2013 |
| Phentermine Hydrochloride;Topiramate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phentermine_HCl_topiramate_ERcaps_22580_RV06-13.pdf | Draft | Oral | Capsule, Extended Release | 022580 | 06/19/2013 |
| Phenytoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phenytoin_oral suspension_RLD 008762_RV03-17.pdf | Draft | Oral | Suspension | 008762 | 05/16/2017 |
| Phenytoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phenytoin_oral chewable tablet_ANDA 084427_RV03-17.pdf | Draft | Oral | Tablet, Chewable | 084427 | 05/16/2017 |
| Phenytoin Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phenytoin_sodium_ERcap_040298_RV12-14.pdf | Draft | Oral | Capsule, Extended Release | 040298 | 12/29/2014 |
| Phenytoin Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phenytoin_sodium_ERcap_084349_RV12-14.pdf | Draft | Oral | Capsule, Extended Release | 084349 | 12/29/2014 |
| Phytonadione | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phytonadione_Inject_87954_87955_83722_RC09-12.pdf | Draft | Injectable | Injection | 012223 | 09/01/2012 |
| Phytonadione | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Phytonadione_oral tablet_RLD010104_RV01-16.pdf | Draft | Oral | Tablet | 010104 | 01/27/2016 |
| Piflufolastat F-18 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214793.pdf | Draft | Intravenous | Solution | 214793 | 05/18/2023 |
| Pilocarpine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214028.pdf | Draft | Ophthalmic | Solution | 214028 | 08/21/2023 |
| Pilocarpine hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PILOCARPINE HYDROCHLORIDE ophthalmic solution NDA 200890 RC 09-2018.pdf | Draft | Ophthalmic | Solution | 200890 | 09/13/2018 |
| Pilocarpine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pilocarpine_tab_20237_RC8-05.pdf | Final | Oral | Tablet | 020237 | 05/12/2008 |
| Pimavanserin Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207318.pdf | Draft | Oral | Tablet | 207318 | 11/18/2020 |
| Pimavanserin Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210793.pdf | Draft | Oral | Capsule | 210793 | 11/21/2019 |
| Pimecrolimus | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021302.pdf | Draft | Topical | Cream | 021302 | 10/21/2022 |
| Pimozide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pimozide_oral tablet_NDA 017473_RV05-17.pdf | Draft | Oral | Tablet | 017473 | 07/13/2017 |
| Pindolol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pindolol_tab_74019_RC02-14.pdf | Draft | Oral | Tablet | 018285 | 04/01/2014 |
| Pioglitazone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pioglitazone_HCl_tab_21073_RC12-09.pdf | Draft | Oral | Tablet | 021073 | 12/17/2009 |
| Pirfenidone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pirfenidone_oral tablet_NDA 208780_RC08-17.pdf | Draft | Oral | Tablet | 208780 | 10/19/2017 |
| Pirfenidone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pirfenidone_oral capsule_022535_RC09-15.pdf | Draft | Oral | Capsule | 022535 | 09/18/2015 |
| Piroxicam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Piroxicam_cap_18147_RC12-12.pdf | Draft | Oral | Capsule | 018147 | 12/14/2012 |
| Pitavastatin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pitavastatin_tab_22363_RC06-11.pdf | Draft | Oral | Tablet | 022363 | 06/30/2011 |
| Pitavastatin magnesium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pitavastatin Magnesium Oral Tablets NDA 208379 RC 09-2018.pdf | Draft | Oral | Tablet | 208379 | 09/13/2018 |
| Pitavastatin sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pitavastatin Sodium Oral Tablet NDA 209875 RC 09-2018.pdf | Draft | Oral | Tablet | 209875 | 09/13/2018 |
| Pitolisant Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211150.pdf | Draft | Oral | Tablet | 211150 | 05/19/2021 |
| Plazomicin Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210303.pdf | Draft | Intravenous | Solution | 210303 | 09/16/2019 |
| Plecanatide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208745.pdf | Draft | Oral | Tablet | 208745 | 09/16/2019 |
| Podofilox | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020529.pdf | Draft | Topical | Gel | 020529 | 10/21/2022 |
| Podofilox | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Podofilox_sol_19795_2_RC08-11.pdf | Draft | Topical | Solution | 019795 | 08/31/2011 |
| Pomalidomide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pomaldiomide_oral capsule_RLD 204026_RV06-16.pdf | Draft | Oral | Capsule | 204026 | 06/16/2016 |
| Ponatinib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ponatinib hydrochloride_oral tablet_203469_RC09-15.pdf | Draft | Oral | Tablet | 203469 | 09/18/2015 |
| Ponesimod | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213498.pdf | Draft | Oral | Tablet | 213498 | 11/17/2022 |
| Posaconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214770.pdf | Draft | Oral | For Suspension, Delayed Release | 214770 | 02/17/2022 |
| Posaconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Posaconazole_Susp_22003_RC11-07.pdf | Draft | Oral | Suspension | 022003 | 11/01/2007 |
| Posaconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Posaconazole_DRtab_205053_RC12-14.pdf | Draft | Oral | Tablet, Delayed Release | 205053 | 12/29/2014 |
| Potassium Chloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Potassium_chloride_ERtab_018279_RC03-15.pdf | Draft | Oral | Tablet, Extended Release | 018279 | 03/06/2015 |
| Potassium Chloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Potassium_Chloride_ERtabs_19123_RC10-11.pdf | Draft | Oral | Tablet, Extended Release | 019123 | 10/27/2011 |
| Potassium Chloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Potassium_Chloride_ERtabs_19439_RC9-11.pdf | Draft | Oral | Tablet, Extended Release | 019439 | 09/29/2011 |
| Potassium Chloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Potassium_Chloride_ERcaps_77419_RC08-11.pdf | Draft | Oral | Capsule, Extended Release | 018238 | 08/31/2011 |
| Potassium Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Potassium citrate_oral ER tablet_NDA 19071_RV11-17.pdf | Draft | Oral | Tablet, Extended Release | 019071 | 02/08/2018 |
| Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212832.pdf | Draft | Intravenous | Solution | 212832 | 11/08/2021 |
| Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212121.pdf | Draft | Intravenous | Solution | 212121 | 11/08/2021 |
| Pralsetinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213721.pdf | Draft | Oral | Capsule | 213721 | 05/19/2022 |
| Pramipexole Dihydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pramipexole_Dihydrochloride_ERtab_22421_RC07-10.pdf | Draft | Oral | Tablet, Extended Release | 022421 | 07/28/2010 |
| Pramipexole Dihydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pramipexole_Dihydrochloride_tab_20667_RC12-08.pdf | Draft | Oral | Tablet | 020667 | 12/20/2008 |
| Prasterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Prasterone_vaginal insert_NDA 208470_RC11-17.pdf | Draft | Vaginal | Insert | 208470 | 02/08/2018 |
| Prasugrel Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Prasugrel hydrochloride_Oral tablet_022307_RV06-15.pdf | Draft | Oral | Tablet | 022307 | 06/24/2015 |
| Pravastatin Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pravastatin_tab_19898_RC8-05.pdf | Final | Oral | Tablet | 019898 | 05/12/2008 |
| Praziquantel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Praziquantel_tablet_18714_RC03-15.pdf | Draft | Oral | Tablet | 018714 | 03/06/2015 |
| Prazosin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Prazosin HCl_oral capsule_RLD 17442_RC12-16.pdf | Draft | Oral | Capsule | 017442 | 12/22/2016 |
| Prednicarbate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Prednicarbate_topical ointment_RLD 19568_RC06-16.pdf | Draft | Topical | Ointment | 019568 | 06/16/2016 |
| Prednisolone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Prednisolone_tab_80354_RC3-09.pdf | Draft | Oral | Tablet | 080354 | 11/26/2010 |
| Prednisolone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Prednisolone_Acetate_tab_22067_RC2-10.pdf | Draft | Oral | Suspension | 022067 | 02/25/2010 |
| Prednisolone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Prednisolone acetate Ophthalmic suspension RLD 017011 PSG Page RV May 2019.pdf | Draft | Ophthalmic | Suspension/Drops | 017011 | 05/15/2019 |
| Prednisolone Sodium Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021959.pdf | Draft | Oral | Tablet, Orally Disintegrating | 021959 | 11/21/2019 |
| Prednisone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202020.pdf | Draft | Oral | Tablet, Delayed Release | 202020 | 08/02/2022 |
| Prednisone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Prednisone_oral tablet_RLD084283_84122_87800_87801_87342_80352 RC01-16.pdf | Draft | Oral | Tablet | 009766 009986 | 01/27/2016 |
| Pregabalin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pregabalin oral extended release tablet NDA 209501 RC 09-2018.pdf | Draft | Oral | Tablet, Extended Release | 209501 | 09/13/2018 |
| Pregabalin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pregabalin_cap_21446_RC5-09.pdf | Final | Oral | Capsule | 021446 | 10/28/2011 |
| Pretomanid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212862.pdf | Draft | Oral | Tablet | 212862 | 11/18/2020 |
| Primaquine Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Primaquine_Phosphate_Oral tab_008316_RC06-15.pdf | Draft | Oral | Tablet | 008316 | 06/24/2015 |
| Primidone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009170.pdf | Draft | Oral | Tablet | 009170 | 11/16/2023 |
| Procarbazine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Procarbazine_cap_16785_RC03-12.pdf | Draft | Oral | Capsule | 016785 | 03/28/2012 |
| Prochlorperazine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Prochlorperazine_Rectal Suppository_RLD 040058_RC09-16.pdf | Draft | Rectal | Suppository | 040058 | 10/04/2016 |
| Prochlorperazine Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010571.pdf | Draft | Oral | Tablet | 010571 | 11/18/2020 |
| Progesterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Progesterone_caps_19781_RC02-11.pdf | Draft | Oral | Capsule | 019781 | 02/23/2011 |
| Progesterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020701.pdf | Draft | Vaginal | Gel | 020701 | 11/17/2022 |
| Progesterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_201110.pdf | Draft | Vaginal | System | 201110 | 02/17/2022 |
| Progesterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Progesterone_insertvag_22057_RC09-12.pdf | Draft | Vaginal | Insert | 022057 | 09/19/2012 |
| Promethazine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Promethazine_Rec_Sup_040428_RC07-14.pdf | Draft | Rectal | Suppository | 010926 | 07/22/2014 |
| Promethazine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Promethazine_Rec_Sup_087165_RC07-14.pdf | Draft | Rectal | Suppository | 011689 | 07/22/2014 |
| Promethazine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Promethazine_HCl_tabs_ 84176_84234_RC2-10.pdf | Draft | Oral | Tablet | 007935 | 02/25/2010 |
| Propafenone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Propafenone hydrochloride_oral tablet_NDA 019151_RV07-17.pdf | Draft | Oral | Tablet | 019151 | 07/13/2017 |
| Propafenone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Propafenone HCL_oral ER capsule_NDA 21416_RV03-17.pdf | Draft | Oral | Capsule, Extended Release | 021416 | 05/16/2017 |
| Propofol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Propofol_injectable injection_RLD 19627_RC06-16.pdf | Draft | Injectable | Injection | 019627 | 06/16/2016 |
| Propranolol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016418.pdf | Draft | Oral | Tablet | 016418 | 11/18/2020 |
| Propranolol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018553.pdf | Draft | Oral | Capsule, Extended Release | 018553 | 11/18/2020 |
| Propranolol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021438.pdf | Draft | Oral | Capsule, Extended Release | 021438 | 11/18/2020 |
| Propylthiouracil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Propythiouracil_tabs_06188_RC03-12.pdf | Draft | Oral | Tablet | 006188 | 03/28/2012 |
| Protriptyline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Protriptyline_HCl_tab_73645_RC12-10.pdf | Draft | Oral | Tablet | 073645 | 12/01/2010 |
| Prucalopride Succinate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210166.pdf | Draft | Oral | Tablet | 210166 | 06/03/2020 |
| Pseudoephedrine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pseudoephedrine HCl_Oral_ER Tab_RLD 073585_RC06-16.pdf | Draft | Oral | Tablet, Extended Release | 073585 | 06/16/2016 |
| Pseudoephedrine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pseudoephedrine_HCl_ERtabs_20021_OTC_RC08-10.pdf | Draft | Oral | Tablet, Extended Release | 020021 | 08/30/2010 |
| Pyrazinamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pyrazinamide_oral tablet_RLD 080157_RC09-16.pdf | Draft | Oral | Tablet | 080157 | 10/04/2016 |
| Pyridostigmine Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pyridostigmine_Bromide_tab_09829_RC8-09.pdf | Final | Oral | Tablet | 009829 | 10/28/2011 |
| Pyridostigmine Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pyridostigmine_ERTabs_11665_RC08-11.pdf | Draft | Oral | Tablet, Extended Release | 011665 | 08/31/2011 |
| Pyrimethamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pyrimethamine_oral tab_008578_RC03-15.pdf | Draft | Oral | Tablet | 008578 | 03/06/2015 |
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 |