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Product-Specific Guidances for Generic Drug Development

To successfully develop and manufacture a generic drug product, an applicant should consider that their product is expected to be: pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use; bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient; and, consequently, therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its reference listed drug.

According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate bioequivalence depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct bioequivalence 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific guidances describing the Agency's current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs.

FDA publishes these product-specific guidances to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, affordable generic drugs

These guidances 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.

Additionally, as part of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), FDA will publish guidances for reference listed drugs that are (1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to the earliest lawful ANDA filing date. 1 This goal does not include complex products as defined in the GDUFA II Commitment Letter. FDA will strive to issue guidance for a complex product as soon as scientific recommendations are available.

In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or bioequivalence (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 product-specific guidances 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 the regulations.gov website (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 product-specific guidances on the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page

For additional information on development of generic drug products, please refer to FDA's guidance document database.

1GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Commitment Letter)

Total number of currently published PSGs: 2032

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


86 record(s) found for 'S'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Sacubitril; Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sacubitril; Valsartan_oral tablet_RLD 207620_RC04-16.pdf Draft Oral Tablet 207620 04/2016
Safinamide Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Safinamide mesylate_oral tablet_NDA 207145_RC11-17.pdf Draft Oral Tablet 207145 02/2018
Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Salmeterol xinafoate_inhalation powder_NDA 020692_RC10-17.pdf Draft Inhalation Powder 020692 10/2017
Sapropterin Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sapropterin dihydrochloride_tab_022181_RC09-12.pdf Draft Oral Tablet 022181 09/2012
Saquinavir Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Saquinavir_Mesylate_tab_21785_RC4-06.pdf Draft Oral Tablet 021785 11/2007
Saquinavir Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Saquinavir_Mesylate_cap_20628_RC11-07.pdf Draft Oral Capsule 020628 11/2007
Sarecycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209521.pdf Draft Oral Tablet 209521 09/2019
Saxagliptin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Saxagliptin_HCl_tab_22350_RC09-12.pdf Draft Oral Tablet 022350 09/2012
Scopolamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017874.pdf Draft Transdermal Film, Extended Release 017874 11/2019
Secnidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Secnidazole Oral Granules NDA 209363 RC 09-2018.pdf Draft Oral Granule 209363 09/2018
Secretin Synthetic Human https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021256.pdf Draft Intravenous For Solution 021256 05/2022
Selegiline https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021336.pdf Draft Transdermal Film, Extended Release 021336 11/2019
Selegiline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Selegiline HCl_oral capsule_RLD 20647_Final 08-17.pdf Final Oral Capsule 020647 08/2017
Selegiline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Selegiline_HCl_ODT_21479_RC9-08.pdf Draft Oral Tablet, Orally Disintegrating 021479 09/2008
Selenious Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209379.pdf Draft Intravenous Solution 209379 03/2020
Selexipag https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207947.pdf Draft Oral Tablet 207947 03/2020
Selinexor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212306.pdf Draft Oral Tablet 212306 05/2022
Selpercatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213246.pdf Draft Oral Capsule 213246 02/2022
Selumetinib Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213756.pdf Draft Oral Capsule 213756 02/2022
Semaglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209637.pdf Draft Subcutaneous Solution 209637 03/2020
Semaglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213051.pdf Draft Oral Tablet 213051 08/2021
Sertraline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sertraline_HCl_tab_19839_RC7-06.pdf Final Oral Tablet 019839 05/2008
Setmelanotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213793.pdf Draft Subcutaneous Solution 213793 08/2022
Sevelamer Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sevelamer_carbonate_oralsusp_022318_RV12-14.pdf Draft Oral Suspension 022318 12/2014
Sevelamer Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sevelamer carbonate_oral tablet_022127_RV09-15.pdf Draft Oral Tablet 022127 09/2015
Sevelamer Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sevelamer_HCl_tab_021179_RV12-14.pdf Draft Oral Tablet 021179 12/2014
Sibutramine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sibutramine_HCl_cap_20632_RC8-05.pdf Final Oral Capsule 020632 05/2008
Sildenafil Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sildenafil_Citrate_tab_20895_21845_RC12-08.pdf Draft Oral Tablet 020895 021845 12/2008
Sildenafil Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sildenafil citrate_oral suspension_203109_RC06-15.pdf Draft Oral Suspension 203109 06/2015
Silodosin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Silodosin_cap_22206_RC04-13.pdf Draft Oral Capsule 022206 04/2013
Silver Sulfadiazine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Silver sulfadiazine_topical cream_NDA 017381_RC05-17.pdf Draft Topical Cream 017381 07/2017
Simeprevir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Simeprevir sodium_Oral capsule_205123_RC06-15.pdf Draft Oral Capsule 205123 06/2015
Simvastatin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Simvastatin_oral suspension_RLD 206679_RC12-16.pdf Draft Oral Suspension 206679 12/2016
Simvastatin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Simvastatin_tab_19766_RC10-05.pdf Final Oral Tablet 019766 05/2008
Simvastatin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Simvastatin_ODtab_21961_RC8-08.pdf Draft Oral Tablet, Orally Disintegrating 021961 08/2008
Simvastatin; Sitagliptin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Simvastatin; Sitagliptin phosphate_oral tablet_NDA 202343_RC11-17.pdf Draft Oral Tablet 202343 02/2018
Siponimod Fumaric Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209884.pdf Draft Oral Tablet 209884 03/2021
Sirolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sirolimus_oral tablet_021110_RV09-15.pdf Draft Oral Tablet 021110 09/2015
Sitagliptin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sitagliptin_Phosphate_tab_21995_RC07-10.pdf Draft Oral Tablet 021995 07/2010
Sodium Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019912.pdf Draft Inhalation Aerosol, Metered 019912 02/2022
Sodium Ferric Gluconate Complex https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sodium_ferric_gluconate_complex_inj_20955_RC06-13.pdf Draft Injectable Injection 020955 06/2013
Sodium Iodide I-131 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016517.pdf Draft Oral Capsule 016517 11/2021
Sodium Iodide I123 https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sodium_Iodide_cap_18671_RC7-08.pdf Draft Oral Capsule 018671 07/2008
Sodium Phenylbutyrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sodium_Phenylbutyrate_pwd_20573_RC5-09.pdf Draft Oral Powder 020573 05/2009
Sodium Phenylbutyrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sodium_Phenylbutyrate_tab_20572_RC5-09.pdf Draft Oral Tablet 020572 05/2009
Sodium Phosphate Dibasic Anhydrous; Sodium Phosphate Monobasic Monohydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sodium_Phosphate_Dibasic_tabs_021097_079247_021892_RC12-12.pdf Draft Oral Tablet 021892 12/2012
Sodium Polystyrene Sulfonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_087859.pdf Draft Oral, Rectal Suspension 087859 08/2020
Sodium Polystyrene Sulfonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/SodiumPolystyreneSulfonatepowderoralrectal011287_RC03-15.pdf Draft Oral/Rectal Powder 011287 03/2015
Sodium Zirconium Cyclosilicate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207078.pdf Draft Oral For Suspension 207078 08/2021
Sofosbuvir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212480.pdf Draft Oral Pellets 212480 03/2021
Sofosbuvir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204671.pdf Draft Oral Tablet 204671 05/2021
Sofosbuvir; Velpatasvir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sofosbuvir; velpatasir_oral tablet_RLD 208341_RC03-17.pdf Draft Oral Tablet 208341 05/2017
Sofosbuvir; Velpatasvir; Voxilaprevir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sofosbuvir Velpatasvir Voxilaprevir Oral Tablets NDA 209195 RC 09-2018.pdf Draft Oral Tablet 209195 09/2018
Solifenacin Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021518.pdf Draft Oral Tablet 021518 05/2022
Solifenacin Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209529.pdf Draft Oral Suspension 209529 05/2022
Solriamfetol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211230.pdf Draft Oral Tablet 211230 03/2021
Sonidegib Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sonidegib phosphate_oral capsule_RLD 205266_RC04-16.pdf Draft Oral Capsule 205266 04/2016
Sorafenib Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sorafenib_Tabs_21923_RC10-11.pdf Draft Oral Tablet 021923 06/2012
Sotalol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sotalol_HCl_tab_19865_RC12-10.pdf Draft Oral Tablet 019865 12/2010
Sotalol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sotalol HCl_oral tablet_ RLD 21151_Final 08-17.pdf Final Oral Tablet 021151 08/2017
Soybean Oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Soybean oil_injectable injection_NDA 019531_RC11-17.pdf Draft Injectable Injection 019531 02/2018
Soybean Oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Soybean oil_injectable injection_NDA 020248, 018449, 017643_RC11-17.pdf Draft Injectable Injection 017643 018449 020248 02/2018
Spinosad https://www.accessdata.fda.gov/drugsatfda_docs/psg/Spinosad_topical suspension_RLD 022408_RC01-16.pdf Draft Topical Suspension 022408 01/2016
Spironolactone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Spironolactone_tabs_12151_RC12-09.pdf Draft Oral Tablet 012151 12/2009
Spironolactone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Spironolactone Suspension Oral NDA 209478 RC 09-2018.pdf Draft Oral Suspension 209478 09/2018
Stavudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Stavudine_cap_20412_RC4-04.pdf Final Oral Capsule 020412 05/2008
Stiripentol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206709.pdf Draft Oral Capsule 206709 03/2020
Stiripentol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207223.pdf Draft Oral For Suspension 207223 03/2020
Succimer https://www.accessdata.fda.gov/drugsatfda_docs/psg/Succimer Oral Capsule 100 mg NDA 019998 RC Feb 2019.pdf Draft Oral Capsule 019998 02/2019
Sucralfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sucralfate_oral suspension_NDA 019183_RV08-17.pdf Draft Oral Suspension 019183 10/2017
Sucralfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018333.pdf Draft Oral Tablet 018333 09/2019
Sufentanil Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209128.pdf Draft Sublingual Tablet 209128 08/2021
Sulfacetamide Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019931.pdf Draft Topical Lotion 019931 11/2019
Sulfadiazine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_004122.pdf Draft Oral Tablet 040091 11/2019
Sulfamethoxazole; Trimethoprim https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sulfamethoxazole; Trimethoprim_oral tablet_NDA 017377_RV11-17.pdf Draft Oral Tablet 017377 02/2018
Sulfamethoxazole;Trimethoprim https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sulfamethoxazole Trimethoprim_Oral suspesion_NDA 017560_RV Oct 2018.pdf Draft Oral Suspension 077612 11/2018
Sulfasalazine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sulfasalazine_tab_07073_RC2-10.pdf Draft Oral Tablet 007073 02/2010
Sulfasalazine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sulfasalazine_DRtab_07073_RC2-10.pdf Draft Oral Tablet, Delayed Release 007073 02/2010
Sulfur Hexafluoride Lipid Type A Microspheres https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sulfur hexafluoridelipid Type-A microspheresuspension 203684RC 09-2018.pdf Draft Intravenous Suspension 203684 09/2018
Sumatriptan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sumatriptan_Nasal spray_NDA 020626_RV Nov 2018.pdf Draft Nasal Spray 020626 11/2018
Sumatriptan https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210884.pdf Draft Nasal Spray 210884 08/2020
Sumatriptan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020080.pdf Draft Subcutaneous Injectable 020080 11/2019
Sumatriptan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206099.pdf Draft Nasal Powder 206099 03/2020
Sumatriptan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sumatriptan_Succinate_tab_20132_RC1-03.pdf Final Oral Tablet 020132 05/2008
Sunitinib Malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sunitinib_Malate_caps_21938_RC04-10.pdf Draft Oral Capsule 021938 04/2010
Suvorexant https://www.accessdata.fda.gov/drugsatfda_docs/psg/Suvorexant_oral tablet_204569_RC09-15.pdf Draft Oral Tablet 204569 09/2015

Newly Added Guidances since August 2022

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acetaminophen; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211733.pdf Draft Oral Tablet 211733 08/2022
Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210526.pdf Draft Oral Tablet, Extended Release 210526 08/2022
Ampicillin/Ampicillin Trihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_064082.pdf Draft Oral Capsule 064082 08/2022
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213872.pdf Draft Nasal Spray, Metered 213872 08/2022
Berotralstat Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214094.pdf Draft Oral Capsule 214094 08/2022
Cabotegravir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212887.pdf Draft Oral Tablet 212887 08/2022
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018281.pdf Draft Oral Tablet, Chewable 018281 08/2022
Caspofungin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021227.pdf Draft Intravenous Powder 021227 08/2022
Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210455.pdf Draft Oral Tablet 210455 08/2022
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214965.pdf Draft Ophthalmic Emulsion 214965 08/2022
Cytarabine; Daunorubicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209401.pdf Draft Intravenous Powder 209401 08/2022
Dasiglucagon Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214231.pdf Draft Subcutaneous Solution 214231 08/2022
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050751.pdf Draft Periodontal System, Extended Release 050751 08/2022
Etonogestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021529.pdf Draft Implantation Implant 021529 08/2022
Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020801.pdf Draft Oral Tablet, Chewable 020801 08/2022
Gallium Ga-68 Gozetotide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212642.pdf Draft Intravenous Solution 212642 212643 08/2022
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020601.pdf Draft Oral Tablet, Chewable 020601 08/2022
Ketoprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018754.pdf Draft Oral Capsule 018754 08/2022
Lonafarnib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213969.pdf Draft Oral Capsule 213969 08/2022
Loperamide Hydrochloride; Simethicone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020606.pdf Draft Oral Tablet, Chewable 020606 08/2022
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210933.pdf Draft Ophthalmic Suspension/Drops 210933 08/2022
Mometasone Furoate; Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211746.pdf Draft Nasal Spray, Metered 211746 08/2022
Nifurtimox https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213464.pdf Draft Oral Tablet 213464 08/2022
Pafolacianine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214907.pdf Draft Intravenous Solution 214907 08/2022
Relugolix https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214621.pdf Draft Oral Tablet 214621 08/2022
Setmelanotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213793.pdf Draft Subcutaneous Solution 213793 08/2022
Technetium Tc-99m Sodium Pertechnetate Generator https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202158.pdf Draft Intravenous, Intravesicular, Ophthalmic Solution 202158 08/2022
Vericiguat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214377.pdf Draft Oral Tablet 214377 08/2022
Vibegron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213006.pdf Draft Oral Tablet 213006 08/2022

Newly Revised Guidances since August 2022

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050726.pdf Draft Oral Tablet, Chewable 050726 08/2022
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020114.pdf Draft Nasal Spray, Metered 020114 08/2022
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021621.pdf Draft Oral Tablet, Chewable 021621 08/2022
Dantrolene Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205579.pdf Draft Intravenous For Suspension 205579 08/2022
Ethinyl Estradiol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021490.pdf Draft Oral Tablet 021490 202086 08/2022
Ethinyl Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203667.pdf Draft Oral Tablet 203667 08/2022
Lamotrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020764.pdf Draft Oral Tablet, For Suspension 020764 08/2022
Lanthanum Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021468.pdf Draft Oral Tablet, Chewable 021468 08/2022
Loratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021891.pdf Draft Oral Tablet, Chewable 021891 08/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012541.pdf Draft Injection Injectable 012541 08/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020246.pdf Draft Injection Injectable 020246 08/2022
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210583.pdf Draft Intravenous Solution 210583 08/2022
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021475.pdf Draft Oral Tablet, Chewable 021475 08/2022
Nicotine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020385.pdf Draft Nasal Spray, Metered 020385 08/2022
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021861.pdf Draft Nasal Spray, Metered 021861 08/2022
Oxymetazoline Hydrochloride; Tetracaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208032.pdf Draft Nasal Spray, Metered 208032 08/2022
Prednisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202020.pdf Draft Oral Tablet, Delayed Release 202020 08/2022
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210115.pdf Draft Oral For Suspension 210115 08/2022
Upadacitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211675.pdf Draft Oral Tablet, Extended Release 211675 08/2022
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