Product-Specific Guidances for Generic Drug Development

Disclaimer: Due to April 2019 systemwide upgrades to www.fda.gov, the filenames for product-specific guidances on this web page may not match the corresponding guidance titles. In such cases, the name on the document correctly identifies the title of the guidance. These discrepancies will be corrected as soon as possible.


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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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

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

 

 

 

Total number of currently published PSGs: 1921

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


106 record(s) found for 'F'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Famciclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Famciclovir_tab_20363_RC8-08.pdf Draft Oral Tablet 020363 08/2008
Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Famotidine_sus_19527_RC12-08.pdf Draft Oral Suspension 019527 12/2008
Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Famotidine_ODtab_21712_RC11-06.pdf Final Oral Tablet, Orally Disintegrating 021712 05/2008
Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Famotidine_tab_19462_RC10-05.pdf Final Oral Tablet 019462 020325 05/2008
Famotidine; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Famotidine; Ibuprofen_Tab_22519_RC06-12.pdf Draft Oral Tablet 022519 06/2012
Febuxostat https://www.accessdata.fda.gov/drugsatfda_docs/psg/Febuxostat_tab_21856_RC2-10.pdf Draft Oral Tablet 021856 02/2010
Fedratinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212327.pdf Draft Oral Capsule 212327 03/2021
Felbamate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Felbamate_oral suspension_NDA 020189_RV11-17.pdf Draft Oral Suspension 020189 02/2018
Felbamate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Felbamate_oral tablet_NDA 020189_RV11-17.pdf Draft Oral Tablet 020189 02/2018
Felodipine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Felodipine_ERtab_78855_RC12-09.pdf Draft Oral Tablet, Extended Release 019834 12/2009
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_oral capsule_RLD 021695 (90 and 30 mg)_RC12-16.pdf Draft Oral Capsule 021695 12/2016
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_tab_76433_RC03-12.pdf Draft Oral Tablet 021203 03/2012
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_cap_75753_RC2-10.pdf Draft Oral Capsule 019304 02/2010
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_tab_22118_RC9-08.pdf Draft Oral Tablet 022118 09/2008
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_cap_21612_RC2-08.pdf Draft Oral Capsule 021612 02/2008
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_cap_21695_RC11-06.pdf Final Oral Capsule 021695 05/2008
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_tab_21656_RC3-02.pdf Final Oral Tablet 021656 05/2008
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_tab_21350_RC10-08.pdf Draft Oral Tablet 021350 10/2008
Fenofibric Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibric_Acid_tabs_22418_RC08-10.pdf Draft Oral Tablet 022418 08/2010
Fenoprofen Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017604.pdf Draft Oral Capsule 017604 03/2021
Fentanyl https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fentanyl_Sublingual spray_202788_RC06-15.pdf Draft Sublingual Spray 202788 06/2015
Fentanyl https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019813.pdf Draft Transdermal Film, Extended Release 019813 11/2019
Fentanyl Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fentanyl_citrate_nasal_22569_RC02-14.pdf Draft Nasal Spray, Metered 022569 04/2014
Fentanyl Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fentanyl_citrate_subltab_22510_RC09-12.pdf Draft Sublingual Tablet 022510 09/2012
Fentanyl Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fentanyl_Citrate_TroLoz_20747_RC2-10.pdf Draft Transmucosal Troche/Lozenge 020747 02/2010
Fentanyl Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fentanyl_citrate_tablet_buccal_21947_RV06-13.pdf Draft Buccal, Sublingual Tablet 021947 06/2013
Ferric Carboxymaltose https://www.accessdata.fda.gov/drugsatfda_docs/psg/FERRIC CARBOXYMALTOSE_injection_RLD 203565_RC04-16.pdf Draft Intravenous Injectable 203565 04/2016
Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 08/2021
Ferric Maltol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212320.pdf Draft Oral Capsule 212320 03/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205109.pdf Draft Oral Tablet, Chewable 205109 09/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021135.pdf Draft Intravenous Injectable 021135 09/2021
Ferumoxytol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ferumoxytol_ivsol_22180_RC12-12.pdf Draft Intravenous Injection 022180 12/2012
Fesoterodine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fesoterodine_Fumarate_ERtab_22030_RC11-10.pdf Draft Oral Tablet, Extended Release 022030 11/2010
Fexofenadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fexofenadine_Hydrochloride_susp_21963_RC12-08.pdf Draft Oral Suspension 021963 12/2008
Fexofenadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fexofenadine_HCl_ODtab_21909_RC8-08.pdf Draft Oral Tablet, Orally Disintegrating 021909 08/2008
Fexofenadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fexofenadine_HCl_cap_20625_RC1-04.pdf Draft Oral Capsule 020625 07/2009
Fexofenadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fexofenadine_HCl_tab_76191_RC2-01.pdf Draft Oral Tablet 020872 09/2008
Fexofenadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_201373.pdf Draft Oral Suspension 201373 09/2019
Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fexofenadine;_Pseudoephedrine_ERtab_20786_21704_RC10-09.pdf Draft Oral Tablet, Extended Release 020786 021704 10/2009
Fidaxomicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/fidaxomicin_oral tablet_RLD 201699_RC08-16 separate posting.pdf Draft Oral Tablet 201699 08/2016
Finafloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Finafloxacin_otic suspension drops_NDA 206307_RC07-18.pdf Draft Otic Suspension, Drops 206307 07/2018
Finasteride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Finasteride_tab_20180_20788_RC1-11.pdf Draft Oral Tablet 020180 020788 01/2011
Fingolimod Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022527.pdf Draft Oral Capsule 022527 09/2019
Fish Oil Triglycerides https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210589.pdf Draft Intravenous Emulsion 210589 06/2020
Fish oil; Medium chain triglycerides; Olive oil; Soybean oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fish oil; Medium chain triglycerides; Olive oil; Soybean oil NDA 207648 Feb 2019.pdf Draft Intravenous Emulsion 207648 02/2019
Flavoxate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016769.pdf Draft Oral Tablet 016769 11/2019
Flecainide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Flecainide_tab_18830_RC2-10.pdf Draft Oral Tablet 018830 02/2010
Flibanserin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Flibanserin_oral tablet_RLD 22526_RC06-16.pdf Draft Oral Tablet 022526 06/2016
Fluconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluconazole_oral tablet_NDA 019949_RV11-17.pdf Draft Oral Tablet 019949 02/2018
Flucytosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Flucytosine_cap_17001_RC07-10.pdf Draft Oral Capsule 017001 07/2010
Fludarabine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fludarabine_tab_22273_RC03-12.pdf Draft Oral Tablet 022273 03/2012
Fludrocortisone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fludrocortisone_Acetate_tab_40431_RC8-09.pdf Final Oral Tablet 010060 10/2011
Fluocinolone acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fuocinolone acetonide_topical cream_NDA 012787_RC07-18.pdf Draft Topical Cream 012787 07/2018
Fluocinolone Acetonide; Hydroquinone; Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluocinolone_Acetonide_Hydroquinone_Tretinoin_crm_21112_RC03-15.pdf Draft Topical Cream 021112 03/2015
Fluocinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluocinonide_topical cream_RLD 21758_RC12-16.pdf Draft Topical Cream 021758 12/2016
Fluocinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluocinonide_topical gel_RLD 074935_RC06-16.pdf Draft Topical Gel 017373 06/2016
Fluocinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluocinonide_topical ointment_RLD 075008_RC 06-16.pdf Draft Topical Ointment 016909 06/2016
Fluocinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluocinonide_topical cream_NDA 019117_RC11-17.pdf Draft Topical Cream 019117 02/2018
Fluorodopa F-18 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200655.pdf Draft Intravenous Solution 200655 11/2020
Fluorometholone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019216.pdf Draft Ophthalmic Suspension/Drops 019216 06/2020
Fluorometholone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorometholone_ophthalmic suspension_NDA 016851_RC08-17.pdf Draft Ophthalmic Drops, Suspension 016851 10/2017
Fluorometholone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019079.pdf Draft Ophthalmic Suspension, Drops 019079 09/2019
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorouracil Topical Cream NDA 016988 RV Feb 2019.pdf Draft Topical Cream 016988 02/2019
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorouracil_sol5_16831_RC03-11.pdf Draft Topical Solution 5% 016831 06/2011
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorouracil_sol2_16831_RC03-11.pdf Draft Topical Solution 2% 016831 06/2011
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorouracil Topical Cream NDA 020985 RV Feb 2019.pdf Draft Topical Cream 020985 02/2019
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorouracil Topical Cream NDA 016831 RV Feb 2019.pdf Draft Topical Cream 016831 02/2019
Fluoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine hcl_oral tablet_RLD 202133_RC12-16.pdf Draft Oral Tablet 202133 12/2016
Fluoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine_HCl_tab_21860_RC2-11.pdf Draft Oral Tablet 021860 02/2011
Fluoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine_HCl_tab_75755_RC2-11.pdf Draft Oral Tablet 020974 02/2011
Fluoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine_HCl_DRcap_21235_RC08-10.pdf Draft Oral Capsule, Delayed Release 021235 08/2010
Fluoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine_HCl_cap_18936_RC06-13.pdf Draft Oral Capsule 018936 06/2013
Fluoxetine Hydrochloride; Olanzapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine_HCl_Olanzapine_cap_21520_RC8-05.pdf Draft Oral Capsule 021520 07/2009
Fluphenazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011751.pdf Draft Oral Tablet 011751 089743 11/2020
Flurandrenolide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Flurandrenolide_topical lotion_RLD 013790_RC01-16.pdf Draft Topical Lotion 013790 01/2016
Flutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Flutamide_Caps_075780_RC04-13.pdf Draft Oral Capsule 018554 04/2013
Fluticasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone furoate_inhalation powder_RLD 205625_RC04-16.pdf Draft Inhalation Powder 205625 04/2016
Fluticasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022051.pdf Draft Nasal Spray, Metered 022051 06/2020
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf Draft Inhalation Powder 209482 05/2021
Fluticasone Furoate; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone furoate; Vilanterol trif_inhal_ pow_204275_RC04-16.pdf Draft Inhalation Powder 204275 04/2016
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone propionate metered inhalation aerosol NDA 021433 RV 07-2018.pdf Draft Inhalation Aerosol, Metered 021433 07/2018
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone proprionate_inhalation powder_NDA 020833_RC10-17.pdf Draft Inhalation Powder 020833 10/2017
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone propionate_topical ointment_RLD 19957_RC09-16.pdf Draft Topical Ointment 019957 10/2016
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone_Propionate_crm_19958_RC2-11.pdf Draft Topical Cream 019958 02/2011
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205434.pdf Draft Nasal Spray, Metered 205434 05/2021
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020121.pdf Draft Nasal Spray, Metered 020121 06/2020
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone Propionate Inhalation Powder NDA 208798 PSG Page RC May 2019.pdf Draft Inhalation Powder 208798 05/2019
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021254.pdf Draft Inhalation Aerosol, Metered 021254 06/2020
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf Draft Inhalation Powder 208799 09/2019
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone Proprionate_Salmeterol Xinafoate_21077_RC09-13.pdf Draft Inhalation Powder 021077 09/2013
Fluvastatin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluvastatin_Sodium_cap_20261_RC1-08.pdf Draft Oral Capsule 020261 01/2008
Fluvastatin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluvastatin_Sodium_ERtab_21192_RC1-08.pdf Draft Oral Tablet, Extended Release 021192 01/2008
Fluvoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluvoxamine_Maleate_ERCaps_22033_RC2-11.pdf Draft Oral Capsule, Extended Release 022033 02/2011
Formoterol Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Formoterol fumarate_Inhalation powder_020831_RC09-15.pdf Draft Inhalation Powder 020831 09/2015
Formoterol Fumarate; Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Formoterol fumarate_Mometasone furoate_inhalation aerosol_RLD 022518_RC01-16.pdf Draft Inhalation Aerosol, Metered 022518 01/2016
Fosamprenavir Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosamprenavir_Calcium_susp_22116_RC11-07.pdf Draft Oral Suspension 022116 11/2007
Fosamprenavir Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosamprenavir_Calcium_tab_21548_RC3-05.pdf Final Oral Tablet 021548 05/2008
Fosfomycin Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosfomycin Tromethamine Oral Solution NDA 050717 PSG Page RV May 2019.pdf Draft Oral For Solution 050717 05/2019
Fosinopril Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosinopril_Sodium_tab_19915_RC5-07.pdf Draft Oral Tablet 019915 05/2008
Fosinopril Sodium; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosinopril_Sodium_HCTZ_tab_20286_RC8-05.pdf Draft Oral Tablet 020286 09/2008
Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosnetupitant and Palonosetron Hydrochloride, powder for injection NDA 210493 PSG Page RC May 2019.pdf Draft Intravenous Powder 210493 05/2019
Fostamatinib Disodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209299.pdf Draft Oral Tablet 209299 09/2019
Fostemsavir Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212950.pdf Draft Oral Tablet, Extended Release 212950 08/2021
Frovatriptan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Frovatriptan_Succinate_tab_21006_RC10-08.pdf Draft Oral Tablet 021006 10/2008
Fulvestrant https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fulvestrant_inj_21344_RC03-12.pdf Draft Injection, Intramuscular Solution 021344 03/2012
Furosemide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Furosemide_Tab_16273_RC09-10.pdf Draft Oral Tablet 016273 09/2010

Newly Added Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202408.pdf Draft Ophthalmic Ointment 202408 08/2021
Albuterol Sulfate; Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf Draft Inhalation Spray, Metered 021747 08/2021
Amisulpride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209510.pdf Draft Intravenous Solution 209510 08/2021
Avapritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212608.pdf Draft Oral Tablet 212608 08/2021
Carbinoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008915.pdf Draft Oral Tablet 008915 08/2021
Cefiderocol Sulfate Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209445.pdf Draft Intravenous Powder 209445 08/2021
Copper Dotatate Cu-64 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213227.pdf Draft Intravenous Solution 213227 08/2021
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214278.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/2021
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021166.pdf Draft Transdermal Gel, Metered 021166 08/2021
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204017.pdf Draft Transdermal System 204017 08/2021
Fostemsavir Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212950.pdf Draft Oral Tablet, Extended Release 212950 08/2021
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017814.pdf Draft Rectal Suppository 017814 08/2021
Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020393.pdf Draft Nasal Spray, Metered 020393 020394 08/2021
Lasmiditan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211280.pdf Draft Oral Tablet 211280 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021343.pdf Draft Subcutaneous Powder 021343 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208219.pdf Draft Ophthalmic Gel 208219 08/2021
Olodaterol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf Draft Inhalation Spray, Metered 203108 08/2021
Osilodrostat Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212801.pdf Draft Oral Tablet 212801 08/2021
Ozanimod Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209899.pdf Draft Oral Capsule 209899 08/2021
Paliperidone Palmitate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207946.pdf Draft Intramuscular Suspension, Extended Release 207946 08/2021
Semaglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213051.pdf Draft Oral Tablet 213051 08/2021
Sufentanil Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209128.pdf Draft Sublingual Tablet 209128 08/2021
Tazemetostat Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211723.pdf Draft Oral Tablet 211723 08/2021

Newly Revised Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Bexarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021055.pdf Draft Oral Capsule 021055 08/2021
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021324.pdf Draft Oral Capsule, Delayed Release 021324 08/2021
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022291.pdf Draft Oral Tablet 022291 08/2021
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207027.pdf Draft Oral For Suspension 207027 08/2021
Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 08/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205109.pdf Draft Oral Tablet, Chewable 205109 09/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021135.pdf Draft Intravenous Injectable 021135 09/2021
Letrozole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020726.pdf Draft Oral Tablet 020726 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019732.pdf Draft Injection Injectable 019732 020011 020263 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020517.pdf Draft Injection Injectable 020517 020708 08/2021
Liothyronine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010379.pdf Draft Oral Tablet 010379 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf Draft Ophthalmic Suspension/Drops 020583 08/2021
Nystatin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060578.pdf Draft Topical Powder 065203 08/2021
Orlistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020766.pdf Draft Oral Capsule 020766 021887 08/2021
Paclitaxel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021660.pdf Draft IV Infusion For Suspension 021660 08/2021
Podofilox https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020529.pdf Draft Topical Gel 020529 08/2021
Sodium Zirconium Cyclosilicate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207078.pdf Draft Oral For Suspension 207078 08/2021
Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021184-Cre-0.05P.pdf Draft Topical Cream 0.05% 021184 08/2021

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English