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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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


70 record(s) found for 'O'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Obeticholic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Obeticholic acid_oral tablet_NDA 207999_RC05-17.pdf Draft Oral Tablet 207999 07/01/2017
Octreotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Octreotide acetate_inj_21008_RV02-14.pdf Draft Injection Injectable 021008 02/01/2014
Octreotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208232.pdf Draft Oral Capsule, Delayed Release 208232 03/01/2021
Octreotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213224.pdf Draft Subcutaneous Solution 213224 03/01/2021
Ofloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ofloxacin_ophthalmic solution drops_NDA 019921_RV08-17.pdf Draft Ophthalmic Solution/Drops 019921 10/01/2017
Olanzapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olanzapine_tab_20592_RC8-08.pdf Draft Oral Tablet 020592 08/01/2008
Olanzapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021086.pdf Draft Oral Tablet, Orally Disintegrating 021086 11/08/2021
Olanzapine Pamoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olanzapine_Intramuscular ER suspension_RLD22173_RC01-16.pdf Draft Intramuscular Suspension, Extended Release 022173 01/01/2016
Olaparib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olaparib_oral capsule_NDA 206162_RC08-17.pdf Draft Oral Capsule 206162 10/01/2017
Olaparib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olaparib Oral Tablet NDA 208558 RC 09-2018.pdf Draft Oral Tablet 208558 09/01/2018
Oliceridine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210730.pdf Draft Intravenous Solution 210730 05/19/2022
Olive Oil; Soybean Oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olive oil; Soybean Oil injectable injection RLD 204508 RC 09-2018.pdf Draft Injection Injectable 204508 09/01/2018
Olmesartan Medoxomil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olmesartan_Medoxomil_tab_21286_RC5-06.pdf Final Oral Tablet 021286 05/01/2008
Olodaterol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf Draft Inhalation Spray, Metered 203108 08/01/2021
Olodaterol Hydrochloride; Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206756.pdf Draft Inhalation Spray, Metered 206756 07/01/2021
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olopatadine HCl_ophthalmic solution_NDA 021545_RV08-17.pdf Draft Ophthalmic Solution/Drops 0.2% 021545 10/01/2017
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olopatadine hydrochloride_ophthalmic solution_NDA 020688_RV08-17.pdf Draft Ophthalmic Solution/Drops 0.1% 020688 10/01/2017
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021861.pdf Draft Nasal Spray, Metered 021861 08/02/2022
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olopatadine hydrochloride_ophthalmic solution_NDA 206276_RC11-17.pdf Draft Ophthalmic Solution/Drops 206276 02/01/2018
Olsalazine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019715.pdf Draft Oral Capsule 019715 03/01/2020
Omadacycline Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209816.pdf Draft Oral Tablet 209816 11/01/2019
Omadacycline Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209817.pdf Draft Intravenous Powder 209817 11/01/2019
Ombitasvir; Paritaprevir; Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ombitasvir_Paritaprevir_Ritonavir_oral tablet_RLD 207931_RC06-16.pdf Draft Oral Tablet 207931 06/01/2016
Omega 3 Acid Ethyl Esters https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021654.pdf Draft Oral Capsule 021654 08/01/2020
Omega3 Acid Ethyl Esters Type A https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omega-3-Acid Ethyl Esters_oral capsule_RLD 204977_RC12-16.pdf Draft Oral Capsule 204977 12/01/2016
Omega3 Carboxylic Acids https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omega-3 Carboxylic Acids_oral capsule_RLD 205060_RV12-16.pdf Draft Oral Capsule 205060 12/01/2016
Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_orally disintegrating DR tablet_NDA 209400_RC07-18.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 209400 07/01/2018
Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_DRtab_022032_RC09-12.pdf Draft Oral Tablet, Delayed Release 022032 09/01/2012
Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_DRcap_19810_RC5-06.pdf Draft Oral Capsule, Delayed Release 019810 11/01/2010
Omeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_Magnesium_DRtabOTC_21229_RC4-06.pdf Final Oral Tablet, Delayed Release 021229 05/01/2008
Omeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole magnesium oral delayed release suspension NDA 022056 PSG Page RC May 2019.pdf Draft Oral For Suspension, Delayed Release 022056 05/01/2019
Omeprazole; Sodium Bicarbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_Sodium bicarbonate_Oral suspension_022283_RC06-15.pdf Draft Oral Suspension, Powder 022283 06/01/2015
Omeprazole; Sodium Bicarbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole;_Sodium Bicarbonate_cap_21849_RC7-08.pdf Draft Oral Capsule 021849 07/01/2008
Omeprazole; Sodium Bicarbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_susp_21636_R5-05.pdf Draft Oral Suspension 021636 07/01/2009
Ondansetron https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ondansetron_oral_film_22524_RC03-12.pdf Draft Oral Film 022524 03/01/2012
Ondansetron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020781.pdf Draft Oral Tablet, Orally Disintegrating 020781 11/08/2021
Ondansetron Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ondansetron_tab_20103_RC5-03.pdf Final Oral Tablet 020103 05/01/2008
Opicapone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212489.pdf Draft Oral Capsule 212489 11/08/2021
Orlistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020766.pdf Draft Oral Capsule 020766 021887 08/01/2021
Orphenadrine Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Orphenadrine_ Citrate_ERtabs_40327_RC04-10.pdf Draft Oral Tablet, Extended Release 012157 04/01/2010
Oseltamivir Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021087.pdf Draft Oral Capsule 021087 05/19/2022
Oseltamivir Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oseltamivir_phosphate_oral susp_21246_RV03-15.pdf Draft Oral Suspension 021246 03/01/2015
Osilodrostat Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212801.pdf Draft Oral Tablet 212801 08/01/2021
Osimertinib Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208065.pdf Draft Oral Tablet 208065 02/17/2022
Ospemifene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ospemifene_tab_203505_RC07-14.pdf Draft Oral Tablet 203505 07/01/2014
Oxaprozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxaprozin_oral tablet_RLD 18841_RC04-16.pdf Draft Oral Tablet 018841 04/01/2016
Oxcarbazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxcarbazepine_ER_Tablets_202810_RC07-14.pdf Draft Oral Tablet, Extended Release 202810 07/01/2014
Oxcarbazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxcarbazepine_susp_21285_RC11-03.pdf Final Oral Suspension 021285 05/01/2008
Oxcarbazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxcarbazepine_tab_21014_RC5-05.pdf Final Oral Tablet 021014 05/01/2008
Oxiconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxiconazole Nitrate Cream NDA 019828 RV Feb 2019.pdf Draft Topical Cream 019828 02/01/2019
Oxiconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxiconazole Nitrate Lotion NDA 020209 RV Feb 2019.pdf Draft Topical Lotion 020209 02/01/2019
Oxybutynin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202211.pdf Draft Transdermal Film, Extended Release 202211 11/01/2019
Oxybutynin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxybutynin_ Transdermal metered gel_202513_RC06-15.pdf Draft Transdermal Gel, Metered 202513 06/01/2015
Oxybutynin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021351.pdf Draft Transdermal Film, Extended Release 021351 11/01/2019
Oxybutynin Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxybutynin chloride_transdermal gel 10_RLD 22204_RC04-16.pdf Draft Transdermal Gel 022204 04/01/2016
Oxybutynin Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxybutynin Chloride_Oral tab_075079_RC03-15.pdf Draft Oral Tablet 075079 03/01/2015
Oxybutynin Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxybutynin_ERtabs_ 20897_RV11-13.pdf Draft Oral Tablet, Extended Release 020897 11/01/2013
Oxycodone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone oral ER capsule NDA 208090 RV 09-2018.pdf Draft Oral Capsule, Extended Release 208090 09/01/2018
Oxycodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone hydrochloride_oral capsule_200534_RC06-15.pdf Draft Oral Capsule 200534 06/01/2015
Oxycodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone hydrochloride_oral ER tablet_NDA 022272_RV07-18.pdf Draft Oral Tablet, Extended Release 022272 07/01/2018
Oxycodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone_tab_21011_12-09.pdf Draft Oral Tablet 021011 12/01/2009
Oxycodone hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone hydrochloride oral tablet NDA 209777 RC 09-2018.pdf Draft Oral Tablet 209777 09/01/2018
Oxymetazoline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208522.pdf Draft Topical Cream 208552 11/01/2019
Oxymetazoline Hydrochloride; Tetracaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208032.pdf Draft Nasal Spray, Metered 208032 08/02/2022
Oxymetholone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxymetholone_tabs_16848_RC2-11.pdf Draft Oral Tablet 016848 02/01/2011
Oxymorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxymorphone HCl_oral ER tablet_RLD 201655_RC09-16.pdf Draft Oral Tablet, Extended Release 201655 10/01/2016
Oxymorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxymorphone_HCl_tab_21611_RC1-08.pdf Draft Oral Tablet 021611 01/01/2008
Oxymorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxymorphone_HCl_ERcap_21610_RC11-07.pdf Draft Oral Tablet, Extended Release 021610 02/01/2010
Ozanimod Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209899.pdf Draft Oral Capsule 209899 08/01/2021
Ozenoxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ozenoxacin topical cream NDA 208945 RC 2019.pdf Draft Topical Cream 208945 02/01/2019

Newly Added Guidances since August 01, 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 08/02/2022
Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210526.pdf Draft Oral Tablet, Extended Release 210526 08/02/2022
Ampicillin/Ampicillin Trihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_064082.pdf Draft Oral Capsule 064082 08/02/2022
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213872.pdf Draft Nasal Spray, Metered 213872 08/02/2022
Berotralstat Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214094.pdf Draft Oral Capsule 214094 08/02/2022
Cabotegravir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212887.pdf Draft Oral Tablet 212887 08/02/2022
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018281.pdf Draft Oral Tablet, Chewable 018281 08/02/2022
Caspofungin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021227.pdf Draft Intravenous Powder 021227 08/02/2022
Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210455.pdf Draft Oral Tablet 210455 08/02/2022
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214965.pdf Draft Ophthalmic Emulsion 214965 08/02/2022
Cytarabine; Daunorubicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209401.pdf Draft Intravenous Powder 209401 08/02/2022
Dasiglucagon Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214231.pdf Draft Subcutaneous Solution 214231 08/02/2022
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050751.pdf Draft Periodontal System, Extended Release 050751 08/02/2022
Etonogestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021529.pdf Draft Implantation Implant 021529 08/02/2022
Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020801.pdf Draft Oral Tablet, Chewable 020801 08/02/2022
Gallium Ga-68 Gozetotide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212642.pdf Draft Intravenous Solution 212642 212643 08/02/2022
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020601.pdf Draft Oral Tablet, Chewable 020601 08/02/2022
Ketoprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018754.pdf Draft Oral Capsule 018754 08/02/2022
Lonafarnib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213969.pdf Draft Oral Capsule 213969 08/02/2022
Loperamide Hydrochloride; Simethicone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020606.pdf Draft Oral Tablet, Chewable 020606 08/02/2022
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210933.pdf Draft Ophthalmic Suspension/Drops 210933 08/02/2022
Mometasone Furoate; Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211746.pdf Draft Nasal Spray, Metered 211746 08/02/2022
Nifurtimox https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213464.pdf Draft Oral Tablet 213464 08/02/2022
Pafolacianine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214907.pdf Draft Intravenous Solution 214907 08/02/2022
Relugolix https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214621.pdf Draft Oral Tablet 214621 08/02/2022
Setmelanotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213793.pdf Draft Subcutaneous Solution 213793 08/02/2022
Technetium Tc-99m Sodium Pertechnetate Generator https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202158.pdf Draft Intravenous, Intravesicular, Ophthalmic Solution 202158 08/02/2022
Vericiguat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214377.pdf Draft Oral Tablet 214377 08/02/2022
Vibegron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213006.pdf Draft Oral Tablet 213006 08/02/2022

Newly Revised Guidances since August 01, 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 08/02/2022
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020114.pdf Draft Nasal Spray, Metered 020114 08/02/2022
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021621.pdf Draft Oral Tablet, Chewable 021621 08/02/2022
Dantrolene Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205579.pdf Draft Intravenous For Suspension 205579 08/02/2022
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 Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203667.pdf Draft Oral Tablet 203667 08/02/2022
Lamotrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020764.pdf Draft Oral Tablet, For Suspension 020764 08/02/2022
Lanthanum Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021468.pdf Draft Oral Tablet, Chewable 021468 08/02/2022
Loratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021891.pdf Draft Oral Tablet, Chewable 021891 08/02/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012541.pdf Draft Injection Injectable 012541 08/02/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020246.pdf Draft Injection Injectable 020246 08/02/2022
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210583.pdf Draft Intravenous Solution 210583 08/02/2022
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021475.pdf Draft Oral Tablet, Chewable 021475 08/02/2022
Nicotine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020385.pdf Draft Nasal Spray, Metered 020385 08/02/2022
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021861.pdf Draft Nasal Spray, Metered 021861 08/02/2022
Oxymetazoline Hydrochloride; Tetracaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208032.pdf Draft Nasal Spray, Metered 208032 08/02/2022
Prednisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202020.pdf Draft Oral Tablet, Delayed Release 202020 08/02/2022
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210115.pdf Draft Oral For Suspension 210115 08/02/2022
Upadacitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211675.pdf Draft Oral Tablet, Extended Release 211675 08/02/2022
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