Product-Specific Guidances for Generic Drug Development

Disclaimer: Due to April 2019 systemwide upgrades to, 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 Questions regarding submission of datasets to CDER may be sent to

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 website ( 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 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

179 record(s) found for 'A'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Abacavir Sulfate Final Oral Tablet 020977 05/2008
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine Draft Oral Tablet 205551 08/2020
Abacavir Sulfate; Lamivudine Draft Oral Tablet 021652 11/2007
Abacavir Sulfate; Lamivudine; Zidovudine Final Oral Tablet 021205 05/2008
Abemaciclib tab_RLD 208716_RC09-18.pdf Draft Oral Tablet 208716 09/2018
Abiraterone Acetate Draft Oral Tablet 210308 06/2020
Abiraterone Acetate acetate_oral tablet_NDA 202379_RV07-18.pdf Draft Oral Tablet 202379 07/2018
Acalabrutinib Oral Capsules NDA 210259 RC Feb 2019.pdf Draft Oral Capsule 210259 02/2019
Acamprosate Calcium calcium_oral DR tablet_RLD 21431 and 202229_RV03-17.pdf Draft Oral Tablet, Delayed Release 021431 05/2017
Acarbose tablet_NDA 20482_final 08-17.pdf Final Oral Tablet 020482 08/2017
Acetaminophen Draft Oral Tablet, Extended Release 019872 02/2011
Acetaminophen; Aspirin; Caffeine; Aspirin; Caffeine_oral tablet_RLD 020802_Final 08-17.pdf Final Oral Tablet 020802 08/2017
Acetaminophen; Benzhydrocodone Hydrochloride Draft Oral Tablet 208653 11/2019
Acetaminophen; Butalbital Butalbital Oral Tablet ANDA 89987 RV Feb 2019.pdf Draft Oral Tablet 089987 02/2019
Acetaminophen; Butalbital;_Butalbital_cap_88831_88889_RC3-10.pdf Draft Oral Capsule 088831 03/2010
Acetaminophen; Butalbital; Caffeine;Butalbital;Caffeine_A89007 A0885 A40885_RV Oct 2018.pdf Draft Oral Capsule 040885 089007 11/2018
Acetaminophen; Butalbital; Caffeine; Butalbital; Caffeine_Oraltablet_ANDA 040511_RV Oct 2018.pdf Draft Oral Tablet 040511 11/2018
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate ; ButalbitalRLD_020232_Final 08-17.pdf Final Oral Capsule 020232 08/2017
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate; Caffeine; Dihydrocodeine Bitartrate Oral Capsule ANDA 204785 RC Feb 2019.pdf Draft Oral Capsule 204785 02/2019
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate;_Caffeine;_Dihydrocodeine_Bitartrate_tab_40316__40109_RC4-09.pdf Final Oral Tablet 040109 10/2011
Acetaminophen; Codeine Phosphate; Codeine Phosphate Tablet ANDA 085055 PSG Page RC May 2019.pdf Draft Oral Tablet 085055 05/2019
Acetaminophen; Hydrocodone Bitartrate 40658; 40556; 40864; 40148; 40099_RV06-16.pdf Draft Oral Tablet 040099 040148 040658 040846 06/2016
Acetaminophen; Oxycodone Hydrochloride;OxycodoneHCL_Oral tablet_ANDA 40330_RV Oct 2018.pdf Draft Oral Tablet 040330 11/2018
Acetaminophen; Oxycodone Hydrochloride; Oxycodone HCL_oral ER tablet_RLD 204031_RC 09-16.pdf Draft Oral Tablet, Extended Release 204031 10/2016
Acetaminophen; Propoxyphene Napsylate;_Propoxyphene_Napsylate_tab_17122_76429_76743_RC2-10.pdf Draft Oral Tablet 076429 02/2010
Acetaminophen; Tramadol Hydrochloride Final Oral Tablet 021123 05/2008
Acetazolamide Oral Tablet NDA 008943 RV 09-2018.pdf Draft Oral Tablet 008943 09/2018
Acetazolamide Draft Oral Capsule, Extended Release 012945 02/2010
Acetylcysteine effervescent tablet_RLD 207916_RC03-17.pdf Draft Oral Tablets, Effervescent 207916 05/2017
Acitretin Capsule_RLD19821_Final 08-17.pdf Final Oral Capsule 019821 08/2017
Aclidinium Bromide bromide_inhalation powder_202450_RC09-15.pdf Draft Inhalation Powder, Metered 202450 09/2015
Acrivastine; Pseudoephedrine Hydrochloride; Pseudoephedrine HCl_draft_Oral cap_RLD 019806_RC07-18.pdf Draft Oral Capsule 019806 07/2018
Acyclovir cream_RLD 21478_RV12-16.pdf Draft Topical Cream 5% 021478 12/2016
Acyclovir Draft Oral Capsule 018828 03/2012
Acyclovir Draft Topical Ointment 018604 09/2019
Acyclovir Draft Ophthalmic Ointment 202408 08/2021
Acyclovir Draft Oral Suspension 019909 09/2019
Acyclovir tablet_203791_RC09-15.pdf Draft Buccal Tablet 203791 09/2015
Acyclovir Final Oral Tablet 020089 05/2008
Adapalene Draft Topical Lotion 022502 11/2019
Adapalene Draft Topical Gel 020380 11/2019
Adapalene Draft Topical Gel 021753 11/2019
Adapalene Draft Topical Cream 020748 11/2019
Adapalene; Benzoyl Peroxide Draft Topical Gel 022320 11/2019
Adapalene; Benzoyl Peroxide Draft Topical Gel 207917 11/2019
Adefovir Dipivoxil Draft Oral Tablet 021449 07/2008
Afatinib Dimaleate dimaleate_Oral tablet_201292_RC06-15.pdf Draft Oral Tablet 201292 06/2015
Albendazole Draft Oral Tablet 020666 06/2020
Albendazole tablet_RLD 207844_RC04-16.pdf Draft Oral Tablet, Chewable 207844 04/2016
Albuterol Sulfate sulfate_oral tablet_RLD 072894_RV06-16.pdf Draft Oral Tablet 017853 06/2016
Albuterol Sulfate Draft Inhalation Aerosol, Metered 020503 021457 020983 03/2020
Albuterol Sulfate Draft Inhalation Powder, Metered 205636 03/2020
Albuterol Sulfate Draft Oral Tablet, Extended Release 019604 03/2020
Albuterol Sulfate; Ipratropium Bromide Draft Inhalation Spray, Metered 021747 08/2021
Alcaftadine solution_NDA 022134_RC11-17.pdf Draft Ophthalmic Solution, Drops 022134 02/2018
Alectinib Hydrochloride HCl_oral capsule_RLD 208434_RC09-16.pdf Draft Oral Capsule 208434 10/2016
Alendronate Sodium Draft Oral Tablet 020560 10/2011
Alendronate Sodium sodium_oral effervescent tablet_202344_RC06-15.pdf Draft Oral Tablet, Effervescent 202344 06/2015
Alendronate Sodium; Cholecalciferol Draft Oral Tablet 021762 10/2011
Alfuzosin Hydrochloride Draft Oral Tablet, Extended Release 021287 11/2007
Aliskiren Hemifumarate Draft Oral Tablet 021985 08/2009
Aliskiren Hemifumarate; Amlodipine Besylate; Amlodipine_Besylate_Tab_22545_RC06-12.pdf Draft Oral Tablet 022545 06/2012
Aliskiren Hemifumarate; Hydrochlorothiazide;_HCTZ_tab_22107_RC8-09.pdf Draft Oral Tablet 022107 08/2009
Aliskiren Hemifumarate; Valsartan;_Valsartan_tab_22217_RC03-11.pdf Draft Oral Tablet 022217 03/2011
Allopurinol Draft Oral Tablet 016084 04/2009
Allopurinol; Lesinurad; Lesinurad_draft_Oral tab_RLD 209203_RC09-18.pdf Draft Oral Tablet 209203 09/2018
Almotriptan Malate Final Oral Tablet 021001 05/2008
Alogliptin Benzoate benzoate_tab_22271_RC07-14.pdf Draft Oral Tablet 022271 07/2014
Alogliptin Benzoate; Metformin Hydrochloride RC07-14.pdf Draft Oral Tablet 203414 07/2014
Alogliptin Benzoate; Pioglitazone Hydrochloride Draft Oral Tablet 022426 07/2014
Alosetron Hydrochloride RC5-05.pdf Final Oral Tablet 021107 05/2008
Alpelisib Draft Oral Tablet 212526 08/2020
Alprazolam Draft Oral Tablet 018276 09/2008
Alprazolam ODtab 21726 RC9-08.pdf Draft Oral Tablet, Orally Disintegrating 021726 09/2008
Alprazolam Draft Oral Tablet, Extended Release 021434 11/2007
Alprostadil suppository_RLD 020700_RC01-16.pdf Draft Urethral Suppository 020700 01/2016
Altretamine Draft Oral Capsule 019926 04/2010
Alvimopan .pdf Draft Oral Capsule 021775 06/2012
Amantadine Hydrochloride Hydrochloride_Oral Capsule_ 071293_RV09-15.pdf Draft Oral Capsule 016020 09/2015
Amantadine Hydrochloride Hydrochloride Oral Extended Release Capsule NDA 208944 RC 09-2018.pdf Draft Oral Capsule, Extended Release 208944 09/2018
Amantadine Hydrochloride Draft Oral Tablet 018101 01/2011
Amantadine Hydrochloride Draft Oral Tablet, Extended Release 209410 09/2019
Ambrisentan Draft Oral Tablet 022081 06/2013
Amcinonide lotion_RLD 76329_RC 06-16.pdf Draft Topical Lotion 076329 06/2016
Amifampridine Phosphate Draft Oral Tablet 208078 03/2020
Amiloride Hydrochloride 70346_RC03-12.pdf Draft Oral Tablet 018200 03/2012
Amino Acids;Calcium Chloride;Dextrose;Magnesium Sulfate;Potassium Chloride;Sodium Acetate;Sodium Glycerophosphate;Soybean Oil Draft Intravenous Emulsion 200656 03/2020
Aminocaproic Acid acid_oral tablet_015197_RC09-15.pdf Draft Oral Tablet 015197 09/2015
Aminosalicylic Acid Draft Oral Granules, Delayed Release 074346 07/2008
Amiodarone Hydrochloride Draft Oral Tablet 018972 12/2010
Amisulpride Draft Intravenous Solution 209510 08/2021
Amitriptyline Hydrochloride Draft Oral Tablet 085966 085967 085968 085969 085970 085971 03/2010
Amitriptyline Hydrochloride; Chlordiazepoxide HCl; Chlordiazepoxide_oral tablet_NDA 16949_RC11-17.pdf Draft Oral Tablet 016949 02/2018
Amlodipine Benzoate Draft Oral Suspension 211340 08/2020
Amlodipine Besylate Final Oral Tablet 019787 05/2008
Amlodipine Besylate; Atorvastatin Calcium;_Atorvastatin_Calcium_tab_21540_RC5-09.pdf Draft Oral Tablet 021540 05/2009
Amlodipine Besylate; Benazepril Hydrochloride Draft Oral Capsule 020364 02/2014
Amlodipine Besylate; Celecoxib Draft Oral Tablet 210045 05/2021
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Draft Oral Tablet 200175 12/2012
Amlodipine Besylate; Olmesartan Medoxomil;_Olmesartan_Medoxomil_tab_22100_RC10-08.pdf Draft Oral Tablet 022100 10/2008
Amlodipine Besylate; Perindopril Arginine besylate; Perinopril arginine_ Oral tablet_RLD 205003_RC04-16.pdf Draft Oral Tablet 205003 04/2016
Amlodipine Besylate; Telmisartan;_Telmisartan_tabs_ 22401_RC08-10.pdf Draft Oral Tablet 022401 08/2010
Amlodipine Besylate; Valsartan;_Valsartan_tab_21990_RC8-08.pdf Draft Oral Tablet 021990 08/2008
Amlodipine Besylate;Hydrochlorothiazide;Valsartan;_HCTZ;_Valsartan_tabs_22314_RC04-10.pdf Draft Oral Tablet 022314 04/2010
Amoxicillin Suspension_RLD 50460_final 08-17.pdf Final Oral Suspension 050460 08/2017
Amoxicillin Suspension_RLD 065119_Final 08-17.pdf Final Oral Suspension 065119 08/2017
Amoxicillin Draft Oral Capsule 050459 09/2012
Amoxicillin Draft Oral Tablet, Chewable 050542 06/2020
Amoxicillin Draft Oral Tablet, Extended Release 050813 04/2013
Amoxicillin; Clarithromycin; Omeprazole Draft Oral Capsule, Tablet, Capsule, Delayed Release 050824 08/2020
Amoxicillin; Clavulanate Potassium Draft Oral Tablet, Extended Release 050785 09/2019
Amoxicillin; Clavulanate Potassium Draft Oral Tablet, Chewable 050597 01/2008
Amoxicillin; Clavulanate Potassium Draft Oral Tablet, Chewable 050726 01/2008
Amoxicillin; Clavulanate Potassium Final Oral Suspension 050725 050755 05/2008
Amoxicillin; Clavulanate Potassium Draft Oral Suspension 050575 09/2012
Amoxicillin; Clavulanate Potassium; Clavulanate potassiumand 050564_Final 08-17.pdf Final Oral Tablet 050564 050720 08/2017
Amoxicillin; Omeprazole Magnesium; Rifabutin Draft Oral Capsule, Delayed Release 213004 08/2020
Amphetamine Draft Oral Suspension, Extended Release 204325 11/2018
Amphetamine ER suspension_RLD 208147_RC12-16.pdf Draft Oral Suspension, Extended Release 208147 12/2016
Amphetamine disintegrating ER tablet_RLD 204326_RC 03-17.pdf Draft Oral Tablet, Orally Disintegrating, Extended Release 204326 05/2017
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Draft Oral Capsule, Extended Release 021303 09/2012
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate_draft_Oral cap ER_RLD 022063_RC09-18.pdf Draft Oral Capsule, Extended Release 022063 09/2018
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Draft Oral Tablet 011522 11/2013
Amphetamine Sulfate sulfate_oral tablet_ANDA 200166_RC11-17.pdf Draft Oral Tablet 200166 02/2018
Amphotericin B Draft Injection Injectable, Liposomal 050740 08/2020
Amprenavir Draft Oral Capsule 021007 08/2008
Anagrelide Hydrochloride Final Oral Capsule 020333 05/2008
Anastrozole Final Oral Tablet 020541 05/2008
Angiotensin II Acetate II ACETATE IV infusion solution NDA 209360 RC Feb 2019.pdf Draft Intravenous Solution 209360 02/2019
Apalutamide Oral Tablets NDA 210951 PSG Page RC May 2019.pdf Draft Oral Tablet 210951 05/2019
Apixaban tablet_NDA 202155_RV05-17.pdf Draft Oral Tablet 202155 05/2017
Apremilast tablet_205437_RC09-15.pdf Draft Oral Tablet 205437 09/2015
Aprepitant for suspension_RLD 207865_RC03-17.pdf Draft Oral Suspension 207865 05/2017
Aprepitant Final Oral Capsule 021549 05/2008
Aprepitant Draft Intravenous Emulsion 209296 06/2020
Aripiprazole Oral Tablet NDA 021436 RV Feb 2019.pdf Draft Oral Tablet 021436 02/2019
Aripiprazole Draft Intramuscular For Suspension, Extended Release 202971 12/2014
Aripiprazole Draft Oral Tablet, Orally Disintegrating 021729 12/2009
Armodafinil Draft Oral Tablet 021875 09/2019
Artemether;Lumefantrine Draft Oral Tablet 022268 06/2013
Asenapine Maleate maleate_Sublingual tablet_NDA 022117_RV Oct 2018.pdf Draft Sublingual Tablet 022117 11/2018
Aspirin capsule_203697_RC06-15.pdf Draft Oral Capsule 203697 06/2015
Aspirin ER capsule_NDA 200671_RC05-17.pdf Draft Oral Capsule, Extended Release 200671 07/2017
Aspirin; Butalbital; Caffeine; Butalbital; Caffeine_oral capsule_ RLD 017534_Final 08-17.pdf Final Oral Capsule 017534 08/2017
Aspirin; Butalbital; Caffeine;_Butalbital;_Caffeine_tab_86162_RC3-10.pdf Final Oral Tablet 017534 08/2017
Aspirin; Butalbital; Caffeine; Codeine Phosphate; Butalbital; Caffeine; Codeine Phosphate 19429_Final 08-17.pdf Final Oral Capsule 019429 08/2017
Aspirin; Dipyridamole;_Dipyridamole_ERcap_20884_RC3-10.pdf Draft Oral Capsule, Extended Release 020884 03/2010
Aspirin; Omeprazole; Omeprazole_oral DR tablet_NDA 205103_RV11-17.pdf Draft Oral Tablets, Delayed Release 205103 02/2018
Aspirin; Oxycodone Hydrochloride; Aspirin;Oxycodone Terephthalate;_Oxycodone_tab_07337_RC2-10.pdf Draft Oral Tablet 007337 02/2010
Atazanavir Sulfate Final Oral Capsule 021567 05/2008
Atazanavir Sulfate; Cobicistat Sulfate and Cobicistat_oral tablet_206353_RC01-16.pdf Draft Oral Tablet 206353 01/2016
Atenolol tablet_ RLD 18240_Final 08-17.pdf Final Oral Tablet 018240 08/2017
Atenolol; Chlorthalidone; Chlorthalidone_oral tablet_ RLD 18760_Final 08-17.pdf Final Oral Tablet 018760 08/2017
Atomoxetine Hydrochloride Final Oral Capsule 021411 05/2008
Atorvastatin Calcium Draft Oral Tablet 020702 10/2010
Atorvastatin Calcium;Ezetimibe ezetimibe_tab_200153_RC02-14.pdf Draft Oral Tablet 200153 04/2014
Atovaquone Draft Oral Tablet 020259 11/2007
Atovaquone Draft Oral Suspension 020500 12/2009
Atovaquone;Proguanil Hydrochloride Draft Oral Tablet 021078 07/2008
Atropine Sulfate;Diphenoxylate Hydrochloride Sulfate; DiphenoxylateHCl_NDA 012462RC Nov 2018.pdf Draft Oral Tablet 012462 11/2018
Auranofin Draft Oral Capsule 018689 02/2010
Avanafil tab_202276_RC03-15.pdf Draft Oral Tablet 202276 03/2015
Avapritinib Draft Oral Tablet 212608 08/2021
Avatrombopag Maleate Draft Oral Tablet 210238 09/2019
Axitinib Draft Oral Tablet 202324 04/2014
Azacitidine Draft Intravenous, Subcutaneous Powder 050794 05/2021
Azathioprine Draft Oral Tablet 016324 09/2010
Azelaic Acid Draft Topical Aerosol, Foam 207071 11/2020
Azelaic Acid Acid Gel 15 NDA 021470 PSG Page RV May 2019.pdf Draft Topical Gel 021470 05/2019
Azelaic Acid Acid Cream 20 NDA 020428 PSG Page RV May 2019.pdf Draft Topical Cream 020428 05/2019
Azelastine Hydrochloride HCl_nasal metered spray_NDA 022203_RC08-17.pdf Draft Nasal Spray, Metered 022203 10/2017
Azelastine Hydrochloride hydrochloride_nasal metered spray_RLD 20114_RC03-17.pdf Draft Nasal Spray, Metered 020114 05/2017
Azelastine Hydrochloride; Fluticasone Propionate Draft Nasal Spray, Metered 202236 06/2020
Azilsartan Kamedoxomil Draft Oral Tablet 200796 06/2012
Azilsartan Kamedoxomil; Chlorthalidone Draft Oral Tablet 202331 03/2015
Azithromycin .pdf Draft Oral Suspension, Extended Release 050797 07/2008
Azithromycin Draft Oral Tablet 050711 050730 050784 01/2008
Azithromycin for suspension_NDA 050693_RC08-17.pdf Draft Oral For Suspension 050693 10/2017
Azithromycin Draft Oral For Suspension 050710 12/2008

Newly Added Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acyclovir Draft Ophthalmic Ointment 202408 08/2021
Albuterol Sulfate; Ipratropium Bromide Draft Inhalation Spray, Metered 021747 08/2021
Amisulpride Draft Intravenous Solution 209510 08/2021
Avapritinib Draft Oral Tablet 212608 08/2021
Carbinoxamine Maleate Draft Oral Tablet 008915 08/2021
Cefiderocol Sulfate Tosylate Draft Intravenous Powder 209445 08/2021
Copper Dotatate Cu-64 Draft Intravenous Solution 213227 08/2021
Esomeprazole Magnesium Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/2021
Estradiol Draft Transdermal Gel, Metered 021166 08/2021
Ethinyl Estradiol; Levonorgestrel Draft Transdermal System 204017 08/2021
Fostemsavir Tromethamine Draft Oral Tablet, Extended Release 212950 08/2021
Indomethacin Draft Rectal Suppository 017814 08/2021
Ipratropium Bromide Draft Nasal Spray, Metered 020393 020394 08/2021
Lasmiditan Succinate Draft Oral Tablet 211280 08/2021
Leuprolide Acetate Draft Subcutaneous Powder 021343 08/2021
Loteprednol Etabonate Draft Ophthalmic Gel 208219 08/2021
Olodaterol Hydrochloride Draft Inhalation Spray, Metered 203108 08/2021
Osilodrostat Phosphate Draft Oral Tablet 212801 08/2021
Ozanimod Hydrochloride Draft Oral Capsule 209899 08/2021
Paliperidone Palmitate Draft Intramuscular Suspension, Extended Release 207946 08/2021
Semaglutide Draft Oral Tablet 213051 08/2021
Sufentanil Citrate Draft Sublingual Tablet 209128 08/2021
Tazemetostat Hydrobromide 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 Draft Oral Capsule 021055 08/2021
Budesonide Draft Oral Capsule, Delayed Release 021324 08/2021
Eltrombopag Olamine Draft Oral Tablet 022291 08/2021
Eltrombopag Olamine Draft Oral For Suspension 207027 08/2021
Ferric Citrate Draft Oral Tablet 205874 08/2021
Ferric Oxyhydroxide Draft Oral Tablet, Chewable 205109 09/2021
Ferric Oxyhydroxide Draft Intravenous Injectable 021135 09/2021
Letrozole Draft Oral Tablet 020726 08/2021
Leuprolide Acetate Draft Injection Injectable 019732 020011 020263 08/2021
Leuprolide Acetate Draft Injection Injectable 020517 020708 08/2021
Liothyronine Sodium Draft Oral Tablet 010379 08/2021
Loteprednol Etabonate Draft Ophthalmic Suspension/Drops 020583 08/2021
Nystatin Draft Topical Powder 065203 08/2021
Orlistat Draft Oral Capsule 020766 021887 08/2021
Paclitaxel Draft IV Infusion For Suspension 021660 08/2021
Podofilox Draft Topical Gel 020529 08/2021
Sodium Zirconium Cyclosilicate Draft Oral For Suspension 207078 08/2021
Tazarotene Draft Topical Cream 0.05% 021184 08/2021

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