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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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
145 record(s) found for 'E'
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Econazole Nitrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Econazole Nitrate Topical Cream NDA 018751 RV Feb 2019.pdf | Draft | Topical | Cream | 018751 | 02/22/2019 |
| Edaravone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209176.pdf | Draft | Intravenous | Solution | 209176 | 03/02/2020 |
| Edaravone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215446.pdf | Draft | Oral | Suspension | 215446 | 11/16/2023 |
| Edoxaban Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206316.pdf | Draft | Oral | Tablet | 206316 | 03/02/2020 |
| Efavirenz | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz_tab_21360_RC11-06.pdf | Final | Oral | Tablet | 021360 | 05/12/2008 |
| Efavirenz | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz_cap_20972_RC10-05.pdf | Final | Oral | Capsule | 020972 | 05/12/2008 |
| Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz_ Emtricitabine_Tenofovir_Disoproxil_Fumarate_tab_21937_RC10-08.pdf | Draft | Oral | Tablet | 021937 | 10/01/2008 |
| Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210649.pdf | Draft | Oral | Tablet | 210649 | 06/03/2020 |
| Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz Lamivudine Tenoforvir Dsisoproxile Funarate Tablets NDA208255 PSG Page RC May 2019.pdf | Draft | Oral | Tablet | 208255 | 05/15/2019 |
| Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz-Lamivudine-Tenofovir Disoproxil Fumarate Oral Tablet NDA 022142 page RC May 2019.pdf | Draft | Oral | Tablet | 022142 | 05/15/2019 |
| Efinaconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efinaconazole_draft_Topical solution_RLD 203567_RC09-18.pdf | Draft | Topical | Solution | 203567 | 09/13/2018 |
| Elagolix Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210450.pdf | Draft | Oral | Tablet | 210450 | 03/02/2020 |
| 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 |
| Elbasvir; Grazoprevir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Elbasvir; Grazoprevir_ Oral Tablet_ RLD 208261_ RC09-16.pdf | Draft | Oral | Tablet | 208261 | 10/04/2016 |
| Eletriptan Hydrobromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eletriptan_HBr_tab_21016_RC5-09.pdf | Final | Oral | Tablet | 021016 | 10/28/2011 |
| Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212273.pdf | Draft | Oral | Tablet, Tablet | 212273 | 03/24/2021 |
| Eliglustat Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eliglustat tartrate_capsule_205494_RC06-15.pdf | Draft | Oral | Capsule | 205494 | 06/24/2015 |
| Eltrombopag Olamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022291.pdf | Draft | Oral | Tablet | 022291 | 08/20/2021 |
| Eltrombopag Olamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207027.pdf | Draft | Oral | For Suspension | 207027 | 08/20/2021 |
| Eluxadoline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eluxadoline_oral tab_RLD 206940_RC04-16.pdf | Draft | Oral | Tablet | 206940 | 04/14/2016 |
| Elvitegravir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Elvitegravir_oral tablet_RLD203093_RC01-16.pdf | Draft | Oral | Tablet | 203093 | 01/27/2016 |
| Empagliflozin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Empagliflozin_oral tablet_204629_RC06-15.pdf | Draft | Oral | Tablet | 204629 | 06/24/2015 |
| Empagliflozin; Linagliptin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Empagliflozin; Linagliptin_oral tablet_RLD 206073_RC04-16.pdf | Draft | Oral | Tablet | 206073 | 04/14/2016 |
| Empagliflozin; Linagliptin; Metformin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212614.pdf | Draft | Oral | Tablet, Extended Release | 212614 | 08/28/2020 |
| Empagliflozin; Metformin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Empagliflozin; Metformin HCl_oral ER tablet_NDA 208658_RC08-17.pdf | Draft | Oral | Tablet, Extended Release | 208658 | 10/19/2017 |
| Empagliflozin; Metformin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Empagliflozin; Metformin hydrochloride_oral tab_RLD 206111_RC06-16.pdf | Draft | Oral | Tablet | 206111 | 06/16/2016 |
| Emtricitabine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Emtricitabine_cap_21500_RC8-05.pdf | Final | Oral | Capsule | 021500 | 08/30/2010 |
| Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Emtricitabine; Rilpivirine HCL; 208351_RV08-17.pdf | Draft | Oral | Tablet | 208351 | 10/19/2017 |
| Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/EmtricitabineRilpivirineHClTenofovir disoproxil fumaratetab202123RC03-15.pdf | Draft | Oral | Tablet | 202123 | 03/06/2015 |
| Emtricitabine; Tenofovir Alafenamide Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208215.pdf | Draft | Oral | Tablet | 208215 | 11/16/2023 |
| Emtricitabine; Tenofovir Disoproxil Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Emtricitabine; Tenofovir disoproxil fumarate_oral tablet_RLD 21752_RV03-17.pdf | Draft | Oral | Tablet | 021752 | 05/16/2017 |
| Enalapril Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Enalapril_Maleate_tab_18998_RC8-08.pdf | Draft | Oral | Tablet | 018998 | 08/01/2008 |
| Enasidenib mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Enasidenib mesylate_draft_Oral tab_RLD 209606_RC09-18.pdf | Draft | Oral | Tablet | 209606 | 09/13/2018 |
| Encorafenib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210496.pdf | Draft | Oral | Capsule | 210496 | 11/21/2019 |
| Enoxaparin Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Enoxaparin_Inj_20164_RC10-11.pdf | Draft | Subcutaneous | Injection | 020164 | 10/28/2011 |
| Entacapone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Entacapone_tab_020796_RV06-13.pdf | Draft | Oral | Tablet | 020796 | 06/19/2013 |
| Entecavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Entecavir_tab_21797_RC5-06.pdf | Final | Oral | Tablet | 021797 | 05/12/2008 |
| Entrectinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212725.pdf | Draft | Oral | Capsule | 212725 | 03/24/2021 |
| Enzalutamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203415.pdf | Draft | Oral | Capsule | 203415 | 02/17/2022 |
| Enzalutamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213674.pdf | Draft | Oral | Tablet | 213674 | 02/17/2022 |
| Epinephrine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205920.pdf | Draft | Inhalation | Aerosol, Metered | 205920 | 08/21/2023 |
| Epinephrine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Epinephrine_intramuscular injection_RLD 19430_RC12-16.pdf | Draft | Intramuscular, Subcutaneous | Injectable | 019430 | 12/22/2016 |
| Epinephrine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_201739.pdf | Draft | Intramuscular, Subcutaneous | Solution | 201739 | 08/21/2023 |
| Epinephrine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Epinephrine_draft_Intramuscular subcutaneous solution_RLD 207534_RC07-18.pdf | Draft | Intramuscular, Subcutaneous | Solution | 207534 | 07/20/2018 |
| Epinephrine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Epinephrine_intramuscular and subcutaneous injectable_NDA 020800_RC08-17.pdf | Draft | Intramuscular/Subcutaneous | Injectable | 020800 | 10/19/2017 |
| Eplerenone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eplerenone_tab_21437_RC3-05.pdf | Final | Oral | Tablet | 021437 | 05/12/2008 |
| Eprosartan Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eprosartan Mesylate_Oral Tablet_RLD 020738_Final 08-17.pdf | Final | Oral | Tablet | 020738 | 08/04/2017 |
| Eprosartan Mesylate; Hydrochlorothiazide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eprosartan_Mesylate;_HCTZ_tab_21268_RC2-08.pdf | Draft | Oral | Tablet | 021268 | 04/06/2008 |
| Eravacycline Dihydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/ERAVACYCLINE DIHYDROCHLORIDE POWDER INTRAVENOUS NDA 211109 PSG Page RC May 2019.pdf | Draft | Intravenous | Powder | 211109 | 05/15/2019 |
| Erdafitinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212018.pdf | Draft | Oral | Tablet | 212018 | 08/28/2020 |
| Ergocalciferol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ergocalciferol_Caps_003444_RV07-14.pdf | Draft | Oral | Capsule | 003444 | 07/22/2014 |
| Erlotinib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erlotinib_HCl_tab_21743_RC1-06.pdf | Final | Oral | Tablet | 021743 | 05/12/2008 |
| Ertugliflozin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ertugliflozin_Oral tablet_NDA 209803_RC Oct 2018.pdf | Draft | Oral | Tablet | 209803 | 11/28/2018 |
| Ertugliflozin; Metformin hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ertugliflozin; Metformin Hydrochloride_Oral tablet_NDA 209806_RC Oct 2018.pdf | Draft | Oral | Tablet | 209806 | 11/28/2018 |
| Ertugliflozin; Sitagliptin phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ertugliflozin; Sitagliptin Phosphateoral_Oral tablet_NDA 209805_RC Oct 2018.pdf | Draft | Oral | Tablet | 209805 | 11/28/2018 |
| Erythromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erythromycin_oral tablet_RLD 061621_RC01-16.pdf | Draft | Oral | Tablet | 061621 | 01/27/2016 |
| Erythromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erythromycin_ophthalmic ointment_RLD 062447_RV09-16.pdf | Draft | Ophthalmic | Ointment | 062447 | 10/04/2016 |
| Erythromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erythromycin_DRtab_62298_RC02-14.pdf | Draft | Oral | Tablet, Delayed Release | 062298 | 04/01/2014 |
| Erythromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erythromycin_swab_64126_RC2-10.pdf | Draft | Topical | Swab | 064126 | 02/01/2010 |
| Erythromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erythromycin_SolTopical_ 64187_RC2-10.pdf | Draft | Topical | Solution | 064187 | 02/01/2010 |
| Erythromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050617.pdf | Draft | Topical | Gel | 050617 | 10/21/2022 |
| Erythromycin Ethylsuccinate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050207.pdf | Draft | Oral | Granule | 050207 | 11/18/2020 |
| Erythromycin Ethylsuccinate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_061904.pdf | Draft | Oral | Tablet | 061904 061905 | 11/18/2020 |
| Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050529.pdf | Draft | Oral | Granule | 050529 | 11/18/2020 |
| Escitalopram Oxalate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Escitalopram_Oxalate_tab_21323_RC10-05.pdf | Final | Oral | Tablet | 021323 | 05/12/2008 |
| Escitalopram Oxalate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Escitalopram_Oxalate_cap_77660_RC9-08.pdf | Draft | Oral | Capsule | 077660 | 09/01/2008 |
| Esketamine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211243.pdf | Draft | Nasal | Spray | 211243 | 08/28/2020 |
| Eslicarbazepine Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eslicarbazepine acetate_oral tablet_022416_RC09-15.pdf | Draft | Oral | Tablet | 022416 | 09/18/2015 |
| Esomeprazole Magnesium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214278.pdf | Draft | Oral | Tablet, Orally Disintegrating, Delayed Release | 214278 | 08/20/2021 |
| Esomeprazole Magnesium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole magnesium_oral DR suspension_NDA 021957 and 022101_RV11-17.pdf | Draft | Oral | Powder For Suspension, Delayed Release | 021957 022101 | 02/08/2018 |
| Esomeprazole Magnesium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204655.pdf | Draft | Oral | Capsule, Delayed Release | 204655 | 08/28/2020 |
| Esomeprazole Magnesium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole magnesium_oral DR capsule pellets_NDA 021153_RV11-17.pdf | Draft | Oral | Capsule, Delayed Release Pellets | 021153 | 02/08/2018 |
| Esomeprazole Magnesium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole magnesium_oral DR tablet_NDA 207920_RV08-17.pdf | Draft | Oral | Tablet, Delayed Release | 207920 | 10/19/2017 |
| Esomeprazole Magnesium; Naproxen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole_Mag;_Naproxen_DRtab_22511_RC03-11.pdf | Draft | Oral | Tablet, Delayed Release | 022511 | 03/01/2011 |
| Esomeprazole Strontium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole Strontium_draft_Oral cap DR_RLD 202342_RC07-18.pdf | Draft | Oral | Capsule, Delayed Release | 202342 | 07/20/2018 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estradiol_tabs_84500_84499_81295_RC_12-10.pdf | Draft | Oral | Tablet | 081295 084499 084500 | 12/01/2010 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203752.pdf | Draft | Transdermal | Film, Extended Release | 203752 | 11/21/2019 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019081.pdf | Draft | Transdermal | Film, Extended Release | 019081 | 11/21/2019 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020375.pdf | Draft | Transdermal | Film, Extended Release | 020375 021674 | 11/21/2019 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020538.pdf | Draft | Transdermal | Film, Extended Release | 020538 | 11/21/2019 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022038.pdf | Draft | Transdermal | Gel | 022038 | 02/17/2022 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021166.pdf | Draft | Transdermal | Gel, Metered | 021166 | 08/20/2021 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021813.pdf | Draft | Transdermal | Gel, Metered | 021813 | 02/17/2022 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022014.pdf | Draft | Transdermal | Spray | 022014 | 02/17/2022 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estradiol_vaginal_tablet_20908_ 08-09.pdf | Draft | Vaginal | Tablet | 020908 | 03/31/2011 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020472.pdf | Draft | Vaginal | Insert, Extended Release | 020472 | 06/03/2020 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estradiol_vaginal_crm_86069_RV09-14.pdf | Draft | Vaginal | Cream | 086069 | 09/19/2014 |
| Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021258.pdf | Draft | Transdermal | Film, Extended Release | 021258 | 08/21/2023 |
| Estradiol; Norethindrone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020870.pdf | Draft | Transdermal | Film, Extended Release | 020870 | 11/21/2019 |
| Estradiol; Norethindrone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Norethindrone_Acetate_(Activella)_tab_20907_RC3-09.pdf | Draft | Oral | Tablet | 020907 | 03/01/2009 |
| Estramustine Phosphate Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estramustine_Caps_018045_RC04-13.pdf | Draft | Oral | Capsule | 018045 | 04/05/2013 |
| Estrogen; Esterified | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esterified estrogen_84948_RC09-12.pdf | Draft | Oral | Tablet | 084948 084949 084950 084951 | 09/01/2012 |
| Estrogens, Conjugated | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Conjugated_estrogens_004782_RC12-14.pdf | Draft | Oral | Tablet | 004782 | 12/29/2014 |
| Estrogens; Conjugated Synthetic A | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estrogens_Conjugated_Synthetic_A_tabs_20992_RC04-10.pdf | Draft | Oral | Tablet | 020992 | 04/20/2010 |
| Eszopiclone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eszopiclone_tab_21476.pdf | Draft | Oral | Tablet | 021476 | 02/23/2008 |
| Etelcalcetide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208325.pdf | Draft | Intravenous | Solution | 208325 | 02/17/2022 |
| Eteplirsen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206488.pdf | Draft | Intravenous | Solution | 206488 | 11/17/2022 |
| Ethacrynic Acid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethacrynic_acid_tab_16092_RC12-10.pdf | Draft | Oral | Tablet | 016092 | 12/23/2010 |
| Ethambutol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethambutol HCl_oral tablet_RLD 016320_Final 08-17.pdf | Final | Oral | Tablet | 016320 | 08/04/2017 |
| Ethinyl Estradiol; Ethynodiol Diacetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Ethynodiol_Diacetate_(Zovia)_tab_72723_72721_RC10-09.pdf | Draft | Oral | Tablet | 072721 072723 | 12/01/2009 |
| Ethinyl Estradiol; Etonogestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol_Etonogestrel_vaginal_ring_21187_RC04-13.pdf | Draft | Vaginal | Ring | 021187 | 04/05/2013 |
| Ethinyl Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204017.pdf | Draft | Transdermal | System | 204017 | 08/20/2021 |
| Ethinyl Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208612.pdf | Draft | Oral | Tablet | 208612 | 03/24/2021 |
| Ethinyl Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209405.pdf | Draft | Oral | Tablet | 209405 | 03/24/2021 |
| Ethinyl Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_estradiol_Levonorgestrel_tab_204061_RV12-14.pdf | Draft | Oral | Tablet | 021544 021840 022262 204061 | 12/29/2014 |
| Ethinyl Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradio;_Levonorgestrel_(Trivora)_tab_74538_RC11-09.pdf | Draft | Oral | Tablet | 019190 019192 | 11/01/2009 |
| Ethinyl Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Levonorgestrel_tab_21864_RC4-09.pdf | Draft | Oral | Tablet | 021864 | 04/01/2009 |
| Ethinyl Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Levonorgestrel_(Nordette)_tab_18782_RC3-09.pdf | Draft | Oral | Tablet | 018782 | 03/01/2009 |
| Ethinyl Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Levonorgestrel_tab_76625_RC3-09.pdf | Draft | Oral | Tablet | 020683 | 03/01/2009 |
| Ethinyl Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Levonorgestrel_(Levite)_20860_RC10-08.pdf | Draft | Oral | Tablet | 020860 | 10/01/2008 |
| Ethinyl Estradiol; Norelgestromin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021180.pdf | Draft | Transdermal | Film, Extended Release | 200910 021180 | 11/21/2019 |
| Ethinyl Estradiol; Norethindrone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol_Norethindone_chewtab_22573_RC03-12.pdf | Draft | Oral | Tablet, Chewable | 022573 | 03/28/2012 |
| Ethinyl Estradiol; Norethindrone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl estradiol and Norethindrone_oral tablets_203006 and 200897 _RV09-15.pdf | Draft | Oral | Tablet | 200897 203006 | 09/18/2015 |
| Ethinyl Estradiol; Norethindrone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Norethindrone_(Trinorinyl)_tab_18977_RC11-09.pdf | Draft | Oral | Tablet | 018977 | 11/23/2009 |
| Ethinyl Estradiol; Norethindrone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021490.pdf | Draft | Oral | Tablet | 021490 202086 | 08/02/2022 |
| Ethinyl Estradiol; Norethindrone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol_Norethindrone__Orthonovum__tab_17919_18985_RC05-09.pdf | Draft | Oral | Tablet | 017735 017919 018985 | 12/01/2010 |
| Ethinyl Estradiol; Norethindrone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol_Norethindrone_LoLoestrin_22501_RC06-11.pdf | Draft | Oral | Tablet | 022501 | 06/30/2011 |
| Ethinyl Estradiol; Norethindrone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/EE;NorethindroneAcetate(Loestrin)tab17355_17875_17354_17876_21871RC10-09.pdf | Draft | Oral | Tablet | 017354 017355 021871 | 10/01/2009 |
| Ethinyl Estradiol; Norethindrone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Norethindrone_Acetate_(Estrostep)_tab_20130_RC7-08.pdf | Draft | Oral | Tablet | 020130 | 07/01/2008 |
| Ethinyl Estradiol; Norethindrone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021065.pdf | Draft | Oral | Tablet | 021065 | 11/17/2022 |
| Ethinyl Estradiol; Norethindrone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203667.pdf | Draft | Oral | Tablet | 203667 | 08/02/2022 |
| Ethinyl estradiol; Norethindrone acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl estradiol; Norethindrone acetate_draft_Oral cap_RLD 204426_RC07-18.pdf | Draft | Oral | Capsule | 204426 | 07/20/2018 |
| Ethinyl Estradiol; Norethindrone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl estradiol_Norethindrone acetate_oral tablet_RLD204654_RC01-16.pdf | Draft | Oral | Tablet, Chewable | 204654 | 01/27/2016 |
| Ethinyl Estradiol; Norgestimate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Norgestimate_tab _19653_19697_21241_RC12-09.pdf | Draft | Oral | Tablet | 019653 019697 021241 | 12/01/2009 |
| Ethinyl Estradiol; Norgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Norgestrel_(Ogestrel)_tab_75406_75288_RC10-09.pdf | Draft | Oral | Tablet | 075288 075406 | 10/01/2009 |
| Ethinyl Estradiol; Segesterone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209627.pdf | Draft | Vaginal | Ring | 209627 | 05/17/2023 |
| Ethiodized Oil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethiodized Oil_intralymphatic intrauterine oil_RLD 009190_RC12-16.pdf | Draft | Intralymphatic, Intrauterine, Selective Hepatic Intra-arterial | Injectable | 009190 | 12/22/2016 |
| Ethionamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethionamide_tab_13026_RC04-13.pdf | Draft | Oral | Tablet | 013026 | 04/05/2013 |
| Ethosuximide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethosuximide_draft_Oral cap_RLD 012380_RC07-18.pdf | Draft | Oral | Capsule | 012380 | 07/20/2018 |
| Etidronate Disodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etidronate_Disodium_tab_17831_RC10-05.pdf | Final | Oral | Tablet | 017831 | 05/12/2008 |
| Etodolac | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etodolac_tab_75074_RC11-13.pdf | Draft | Oral | Tablet | 018922 | 11/05/2013 |
| Etodolac | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etodolac_cap_75078_RC11-13.pdf | Draft | Oral | Capsule | 018922 | 11/05/2013 |
| Etodolac | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etodolac_ERtabs_75665_RC07-10.pdf | Draft | Oral | Tablet, Extended Release | 020584 | 07/28/2010 |
| Etonogestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021529.pdf | Draft | Implantation | Implant | 021529 | 08/02/2022 |
| Etoposide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etoposide_caps_75635_RC08-10.pdf | Draft | Oral | Capsule | 075635 | 08/30/2010 |
| Etravirine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etravirine_tab_22187_RC09-12.pdf | Draft | Oral | Tablet | 022187 | 09/19/2012 |
| Everolimus | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Everolimus_draft_Oral tab_RLD 22334_RC11-18.pdf | Draft | Oral | Tablet | 022334 | 11/28/2018 |
| Everolimus | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Everolimus_oral tablet for suspension_NDA 203985_RC08-17.pdf | Draft | Oral | Tablet, For Suspension | 203985 | 10/19/2017 |
| Everolimus | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021560.pdf | Draft | Oral | Tablet | 021560 | 06/03/2020 |
| Exemestane | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Exemestane_tab_20753_RC10-05.pdf | Final | Oral | Tablet | 020753 | 05/12/2008 |
| Exenatide Synthetic | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022200.pdf | Draft | Subcutaneous | For Suspension, Extended Release | 022200 | 05/19/2022 |
| Exenatide Synthetic | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209210.pdf | Draft | Subcutaneous | Suspension, Extended Release | 209210 | 05/19/2022 |
| Ezetimibe | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ezetimibe_tab_21445_RC10-08.pdf | Draft | Oral | Tablet | 021445 | 10/01/2008 |
| Ezetimibe; Simvastatin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ezetimibe;_Simvastatin_tab_21687_RC9-08.pdf | Draft | Oral | Tablet | 021687 | 09/01/2008 |
| Ezogabine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ezogabine_tab_22345_RC04-13.pdf | Draft | Oral | Tablet | 022345 | 04/05/2013 |
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 |