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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).

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.

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

 

 

 

Total number of currently published PSGs: 1896

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


175 record(s) found for 'A'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Abacavir Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abacavir_Sulfate_tab_20977_RC5-06.pdf Final Oral Tablet 020977 05/2008
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205551.pdf Draft Oral Tablet 205551 08/2020
Abacavir Sulfate; Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abacavir_Sulfate_Lamivudine_tab_21652_RC7-06.pdf Draft Oral Tablet 021652 11/2007
Abacavir Sulfate; Lamivudine; Zidovudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abacavir_Lamivudine_Zidovudine_tab_21205_RC9-05.pdf Final Oral Tablet 021205 05/2008
Abemaciclib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abemaciclib_draft_Oral tab_RLD 208716_RC09-18.pdf Draft Oral Tablet 208716 09/2018
Abiraterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210308.pdf Draft Oral Tablet 210308 06/2020
Abiraterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abiraterone acetate_oral tablet_NDA 202379_RV07-18.pdf Draft Oral Tablet 202379 07/2018
Acalabrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acalabrutinib Oral Capsules NDA 210259 RC Feb 2019.pdf Draft Oral Capsule 210259 02/2019
Acamprosate Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acamprosate calcium_oral DR tablet_RLD 21431 and 202229_RV03-17.pdf Draft Oral Tablet, Delayed Release 021431 05/2017
Acarbose https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acarbose_oral tablet_NDA 20482_final 08-17.pdf Final Oral Tablet 020482 08/2017
Acetaminophen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen_ERtab_19872_RC2-11.pdf Draft Oral Tablet, Extended Release 019872 02/2011
Acetaminophen; Aspirin; Caffeine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen; Aspirin; Caffeine_oral tablet_RLD 020802_Final 08-17.pdf Final Oral Tablet 020802 08/2017
Acetaminophen; Benzhydrocodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208653.pdf Draft Oral Tablet 208653 11/2019
Acetaminophen; Butalbital https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen Butalbital Oral Tablet ANDA 89987 RV Feb 2019.pdf Draft Oral Tablet 089987 02/2019
Acetaminophen; Butalbital https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen;_Butalbital_cap_88831_88889_RC3-10.pdf Draft Oral Capsule 088831 03/2010
Acetaminophen; Butalbital; Caffeine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen;Butalbital;Caffeine_A89007 A0885 A40885_RV Oct 2018.pdf Draft Oral Capsule 040885 089007 11/2018
Acetaminophen; Butalbital; Caffeine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen; Butalbital; Caffeine_Oraltablet_ANDA 040511_RV Oct 2018.pdf Draft Oral Tablet 040511 11/2018
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen ; ButalbitalRLD_020232_Final 08-17.pdf Final Oral Capsule 020232 08/2017
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen; Caffeine; Dihydrocodeine Bitartrate Oral Capsule ANDA 204785 RC Feb 2019.pdf Draft Oral Capsule 204785 02/2019
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen;_Caffeine;_Dihydrocodeine_Bitartrate_tab_40316__40109_RC4-09.pdf Final Oral Tablet 040109 10/2011
Acetaminophen; Codeine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen; Codeine Phosphate Tablet ANDA 085055 PSG Page RC May 2019.pdf Draft Oral Tablet 085055 05/2019
Acetaminophen; Hydrocodone Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen_Hydro_bit 40658; 40556; 40864; 40148; 40099_RV06-16.pdf Draft Oral Tablet 040099 040148 040658 040846 06/2016
Acetaminophen; Oxycodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen;OxycodoneHCL_Oral tablet_ANDA 40330_RV Oct 2018.pdf Draft Oral Tablet 040330 11/2018
Acetaminophen; Oxycodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen; Oxycodone HCL_oral ER tablet_RLD 204031_RC 09-16.pdf Draft Oral Tablet, Extended Release 204031 10/2016
Acetaminophen; Propoxyphene Napsylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen;_Propoxyphene_Napsylate_tab_17122_76429_76743_RC2-10.pdf Draft Oral Tablet 076429 02/2010
Acetaminophen; Tramadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tramadol_HCl_Acetaminophen_tab_21123_RC1-06.pdf Final Oral Tablet 021123 05/2008
Acetazolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetazolamide Oral Tablet NDA 008943 RV 09-2018.pdf Draft Oral Tablet 008943 09/2018
Acetazolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetazolamide_ERcaps_12945_RC2-10.pdf Draft Oral Capsule, Extended Release 012945 02/2010
Acetylcysteine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetylcystein_oral effervescent tablet_RLD 207916_RC03-17.pdf Draft Oral Tablets, Effervescent 207916 05/2017
Acitretin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acitretin_Oral Capsule_RLD19821_Final 08-17.pdf Final Oral Capsule 019821 08/2017
Aclidinium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aclidinium bromide_inhalation powder_202450_RC09-15.pdf Draft Inhalation Powder, Metered 202450 09/2015
Acrivastine; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acrivastine; Pseudoephedrine HCl_draft_Oral cap_RLD 019806_RC07-18.pdf Draft Oral Capsule 019806 07/2018
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018604.pdf Draft Topical Ointment 018604 09/2019
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019909.pdf Draft Oral Suspension 019909 09/2019
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acyclovir_cap_18828_RC03-12.pdf Draft Oral Capsule 018828 03/2012
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acyclovir_topical cream_RLD 21478_RV12-16.pdf Draft Topical Cream 5% 021478 12/2016
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acyclovir_buccal tablet_203791_RC09-15.pdf Draft Buccal Tablet 203791 09/2015
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acyclovir_tab_20089_RC8-05.pdf Final Oral Tablet 020089 05/2008
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020748.pdf Draft Topical Cream 020748 11/2019
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020380.pdf Draft Topical Gel 020380 11/2019
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021753.pdf Draft Topical Gel 021753 11/2019
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022502.pdf Draft Topical Lotion 022502 11/2019
Adapalene; Benzoyl Peroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022320.pdf Draft Topical Gel 022320 11/2019
Adapalene; Benzoyl Peroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207917.pdf Draft Topical Gel 207917 11/2019
Adefovir Dipivoxil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Adefovir_Dipivoxil_tab_21449_RC7-08.pdf Draft Oral Tablet 021449 07/2008
Afatinib Dimaleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Afatinib dimaleate_Oral tablet_201292_RC06-15.pdf Draft Oral Tablet 201292 06/2015
Albendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020666.pdf Draft Oral Tablet 020666 06/2020
Albendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Albendazole_Chewble tablet_RLD 207844_RC04-16.pdf Draft Oral Tablet, Chewable 207844 04/2016
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019604.pdf Draft Oral Tablet, Extended Release 019604 03/2020
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Albuterol sulfate_oral tablet_RLD 072894_RV06-16.pdf Draft Oral Tablet 017853 06/2016
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020503.pdf Draft Inhalation Aerosol, Metered 020503 021457 020983 03/2020
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205636.pdf Draft Inhalation Powder, Metered 205636 03/2020
Alcaftadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alcaftadine_ophthalmic solution_NDA 022134_RC11-17.pdf Draft Ophthalmic Solution, Drops 022134 02/2018
Alectinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alectinib HCl_oral capsule_RLD 208434_RC09-16.pdf Draft Oral Capsule 208434 10/2016
Alendronate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alendronate__Sodium_tab_20560_RC1-08.pdf Draft Oral Tablet 020560 10/2011
Alendronate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alendronate sodium_oral effervescent tablet_202344_RC06-15.pdf Draft Oral Tablet, Effervescent 202344 06/2015
Alendronate Sodium; Cholecalciferol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alendronate_Cholecalciferol_tab_21762_RC4-09.pdf Draft Oral Tablet 021762 10/2011
Alfuzosin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alfuzosin_ERtab_21287_RC7-04.pdf Draft Oral Tablet, Extended Release 021287 11/2007
Aliskiren Hemifumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aliskiren_Hemifumarate_tab_21985_RC8-09.pdf Draft Oral Tablet 021985 08/2009
Aliskiren Hemifumarate; Amlodipine Besylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aliskiren_Hemifumarate; Amlodipine_Besylate_Tab_22545_RC06-12.pdf Draft Oral Tablet 022545 06/2012
Aliskiren Hemifumarate; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aliskiren;_HCTZ_tab_22107_RC8-09.pdf Draft Oral Tablet 022107 08/2009
Aliskiren Hemifumarate; Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aliskiren_Hemifumarate;_Valsartan_tab_22217_RC03-11.pdf Draft Oral Tablet 022217 03/2011
Allopurinol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Allopurinol_tab_16084_RC4-09.pdf Draft Oral Tablet 016084 04/2009
Allopurinol; Lesinurad https://www.accessdata.fda.gov/drugsatfda_docs/psg/Allopurinol; Lesinurad_draft_Oral tab_RLD 209203_RC09-18.pdf Draft Oral Tablet 209203 09/2018
Almotriptan Malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Almotriptan_Malate_tab_21001_RC5-05.pdf Final Oral Tablet 021001 05/2008
Alogliptin Benzoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alogliptin benzoate_tab_22271_RC07-14.pdf Draft Oral Tablet 022271 07/2014
Alogliptin Benzoate; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alogliptin_benzoate_Metformin_HCl_tab_203414 RC07-14.pdf Draft Oral Tablet 203414 07/2014
Alogliptin Benzoate; Pioglitazone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alogliptin_benzoate_Pioglitazone_tab_22426_RC07-14.pdf Draft Oral Tablet 022426 07/2014
Alosetron Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alosetron_HCl_tab_21107_ RC5-05.pdf Final Oral Tablet 021107 05/2008
Alpelisib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212526.pdf Draft Oral Tablet 212526 08/2020
Alprazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alprazolam_tab_18276_RC3-05.pdf Draft Oral Tablet 018276 09/2008
Alprazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alprazolam_tab_21434_RC6-04.pdf Draft Oral Tablet, Extended Release 021434 11/2007
Alprazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alprazolam ODtab 21726 RC9-08.pdf Draft Oral Tablet, Orally Disintegrating 021726 09/2008
Alprostadil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alprostadil_urethral suppository_RLD 020700_RC01-16.pdf Draft Urethral Suppository 020700 01/2016
Altretamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Altretamine_caps_19926_RC04-10.pdf Draft Oral Capsule 019926 04/2010
Alvimopan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alvimopan_Cap_21775_RC06-12 .pdf Draft Oral Capsule 021775 06/2012
Amantadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amamtadine Hydrochloride_Oral Capsule_ 071293_RV09-15.pdf Draft Oral Capsule 016020 09/2015
Amantadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amantadine Hydrochloride Oral Extended Release Capsule NDA 208944 RC 09-2018.pdf Draft Oral Capsule, Extended Release 208944 09/2018
Amantadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amantadine_HCl_tab_76186_RC11-10.pdf Draft Oral Tablet 018101 01/2011
Amantadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209410.pdf Draft Oral Tablet, Extended Release 209410 09/2019
Ambrisentan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ambrisentan_tab_22081_RV06-13.pdf Draft Oral Tablet 022081 06/2013
Amcinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amcinonide_topical lotion_RLD 76329_RC 06-16.pdf Draft Topical Lotion 076329 06/2016
Amifampridine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208078.pdf Draft Oral Tablet 208078 03/2020
Amiloride Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amiloride_tab_ 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 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200656.pdf Draft Intravenous Emulsion 200656 03/2020
Aminocaproic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aminocaproic acid_oral tablet_015197_RC09-15.pdf Draft Oral Tablet 015197 09/2015
Aminosalicylic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aminosalicylic_Acid_DRgran_74346_RC7-08.pdf Draft Oral Granules, Delayed Release 074346 07/2008
Amiodarone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amiodarone_HCl_tab_18972_RC12-10.pdf Draft Oral Tablet 018972 12/2010
Amitriptyline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amitriptyline_HCl_tab_85966_85969_85968_85971_85967_85970_RC3-10.pdf Draft Oral Tablet 085966 085967 085968 085969 085970 085971 03/2010
Amitriptyline Hydrochloride; Chlordiazepoxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amitriptyline HCl; Chlordiazepoxide_oral tablet_NDA 16949_RC11-17.pdf Draft Oral Tablet 016949 02/2018
Amlodipine Benzoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211340.pdf Draft Oral Suspension 211340 08/2020
Amlodipine Besylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Besylate_tab_19787_RC6-03.pdf Final Oral Tablet 019787 05/2008
Amlodipine Besylate; Atorvastatin Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Besylate;_Atorvastatin_Calcium_tab_21540_RC5-09.pdf Draft Oral Tablet 021540 05/2009
Amlodipine Besylate; Benazepril Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_benazepril_020364_RV02-14.pdf Draft Oral Capsule 020364 02/2014
Amlodipine Besylate; Celecoxib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210045.pdf Draft Oral Tablet 210045 05/2021
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Hydrochlorothiazide_Olmesartin_tab_200175_RC12-12.pdf Draft Oral Tablet 200175 12/2012
Amlodipine Besylate; Olmesartan Medoxomil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Besylate;_Olmesartan_Medoxomil_tab_22100_RC10-08.pdf Draft Oral Tablet 022100 10/2008
Amlodipine Besylate; Perindopril Arginine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine besylate; Perinopril arginine_ Oral tablet_RLD 205003_RC04-16.pdf Draft Oral Tablet 205003 04/2016
Amlodipine Besylate; Telmisartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Besylate;_Telmisartan_tabs_ 22401_RC08-10.pdf Draft Oral Tablet 022401 08/2010
Amlodipine Besylate; Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Besylate;_Valsartan_tab_21990_RC8-08.pdf Draft Oral Tablet 021990 08/2008
Amlodipine Besylate;Hydrochlorothiazide;Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine;_HCTZ;_Valsartan_tabs_22314_RC04-10.pdf Draft Oral Tablet 022314 04/2010
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Oral Suspension_RLD 50460_final 08-17.pdf Final Oral Suspension 050460 08/2017
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Oral Suspension_RLD 065119_Final 08-17.pdf Final Oral Suspension 065119 08/2017
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_cap_061926_RC09-12.pdf Draft Oral Capsule 050459 09/2012
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_ERtab_50813_RC04-13.pdf Draft Oral Tablet, Extended Release 050813 04/2013
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050542.pdf Draft Oral Tablet, Chewable 050542 06/2020
Amoxicillin; Clarithromycin; Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050824.pdf Draft Oral Capsule, Tablet, Capsule, Delayed Release 050824 08/2020
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050785.pdf Draft Oral Tablet, Extended Release 050785 09/2019
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Clavu_chew_50597_RC1-08.pdf Draft Oral Tablet, Chewable 050597 01/2008
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Clavu_chew_50726_RC1-08.pdf Draft Oral Tablet, Chewable 050726 01/2008
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Clavulanate_Potassium_susp_50755_RC7-05..pdf Final Oral Suspension 050725 050755 05/2008
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Clavulanate_potassium_susp_50575_RC09-12.pdf Draft Oral Suspension 050575 09/2012
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin; Clavulanate potassiumand 050564_Final 08-17.pdf Final Oral Tablet 050564 050720 08/2017
Amoxicillin; Omeprazole Magnesium; Rifabutin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213004.pdf Draft Oral Capsule, Delayed Release 213004 08/2020
Amphetamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_orally_disintegrating_ER_tablet_RLD_204326_RC_03-17.pdf Draft Oral Suspension, Extended Release 204325 11/2018
Amphetamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_oral ER suspension_RLD 208147_RC12-16.pdf Draft Oral Suspension, Extended Release 208147 12/2016
Amphetamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_orally 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 https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_Aspartate_21303_RC09-12.pdf Draft Oral Capsule, Extended Release 021303 09/2012
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine 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 https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_aspartate__40422_RV11-13.pdf Draft Oral Tablet 011522 11/2013
Amphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine sulfate_oral tablet_ANDA 200166_RC11-17.pdf Draft Oral Tablet 200166 02/2018
Amphotericin B https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050740.pdf Draft Injection Injectable, Liposomal 050740 08/2020
Amprenavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amprenavir_cap_21007_RC8-08.pdf Draft Oral Capsule 021007 08/2008
Anagrelide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Anagrelide_HCl_cap_20333_RC5-05.pdf Final Oral Capsule 020333 05/2008
Anastrozole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Anastrozole_tab_20541_RC10-05.pdf Final Oral Tablet 020541 05/2008
Angiotensin II Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ANGIOTENSIN II ACETATE IV infusion solution NDA 209360 RC Feb 2019.pdf Draft Intravenous Solution 209360 02/2019
Apalutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Apalutamide Oral Tablets NDA 210951 PSG Page RC May 2019.pdf Draft Oral Tablet 210951 05/2019
Apixaban https://www.accessdata.fda.gov/drugsatfda_docs/psg/Apixaban_oral tablet_NDA 202155_RV05-17.pdf Draft Oral Tablet 202155 05/2017
Apremilast https://www.accessdata.fda.gov/drugsatfda_docs/psg/Apremilast_Oral tablet_205437_RC09-15.pdf Draft Oral Tablet 205437 09/2015
Aprepitant https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aprepitan_oral for suspension_RLD 207865_RC03-17.pdf Draft Oral Suspension 207865 05/2017
Aprepitant https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aprepitant_cap_21549_RC10-05.pdf Final Oral Capsule 021549 05/2008
Aprepitant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209296.pdf Draft Intravenous Emulsion 209296 06/2020
Aripiprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aripiprazole Oral Tablet NDA 021436 RV Feb 2019.pdf Draft Oral Tablet 021436 02/2019
Aripiprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aripiprazole_ERinjecsusp_202971_RC12-14.pdf Draft Intramuscular For Suspension, Extended Release 202971 12/2014
Aripiprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aripiprazole_ODT_21729_RC12-09.pdf Draft Oral Tablet, Orally Disintegrating 021729 12/2009
Armodafinil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021875.pdf Draft Oral Tablet 021875 09/2019
Artemether;Lumefantrine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Artemether_lumefantrine_tab_22268_RC06-13.pdf Draft Oral Tablet 022268 06/2013
Asenapine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Asenapine maleate_Sublingual tablet_NDA 022117_RV Oct 2018.pdf Draft Sublingual Tablet 022117 11/2018
Aspirin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin_oral ER capsule_NDA 200671_RC05-17.pdf Draft Oral Capsule, Extended Release 200671 07/2017
Aspirin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin_oral capsule_203697_RC06-15.pdf Draft Oral Capsule 203697 06/2015
Aspirin; Butalbital; Caffeine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin; Butalbital; Caffeine_oral capsule_ RLD 017534_Final 08-17.pdf Final Oral Capsule 017534 08/2017
Aspirin; Butalbital; Caffeine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin;_Butalbital;_Caffeine_tab_86162_RC3-10.pdf Final Oral Tablet 017534 08/2017
Aspirin; Butalbital; Caffeine; Codeine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin; Butalbital; Caffeine; Codeine Phosphate 19429_Final 08-17.pdf Final Oral Capsule 019429 08/2017
Aspirin; Dipyridamole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin;_Dipyridamole_ERcap_20884_RC3-10.pdf Draft Oral Capsule, Extended Release 020884 03/2010
Aspirin; Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin; Omeprazole_oral DR tablet_NDA 205103_RV11-17.pdf Draft Oral Tablets, Delayed Release 205103 02/2018
Aspirin; Oxycodone Hydrochloride; Aspirin;Oxycodone Terephthalate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin;_Oxycodone_tab_07337_RC2-10.pdf Draft Oral Tablet 007337 02/2010
Atazanavir Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atazanavir_Sulfate_cap_21567_RC3-05.pdf Final Oral Capsule 021567 05/2008
Atazanavir Sulfate; Cobicistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atazanavir Sulfate and Cobicistat_oral tablet_206353_RC01-16.pdf Draft Oral Tablet 206353 01/2016
Atenolol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atenolol_oral tablet_ RLD 18240_Final 08-17.pdf Final Oral Tablet 018240 08/2017
Atenolol; Chlorthalidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atenolol; Chlorthalidone_oral tablet_ RLD 18760_Final 08-17.pdf Final Oral Tablet 018760 08/2017
Atomoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atomoxetine_HCl_cap_21411_RC11-50.pdf Final Oral Capsule 021411 05/2008
Atorvastatin Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atorvastatin_tabs_20702_RC5-08.pdf Draft Oral Tablet 020702 10/2010
Atorvastatin Calcium;Ezetimibe https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atorvastatin ezetimibe_tab_200153_RC02-14.pdf Draft Oral Tablet 200153 04/2014
Atovaquone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atovaquone_tab_20259_RC5-05.pdf Draft Oral Tablet 020259 11/2007
Atovaquone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atovaquone_susp_20500_RC12-09.pdf Draft Oral Suspension 020500 12/2009
Atovaquone;Proguanil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atovaquone__Proguanil_tab_21078_RC7-08.pdf Draft Oral Tablet 021078 07/2008
Atropine Sulfate;Diphenoxylate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atropine Sulfate; DiphenoxylateHCl_NDA 012462RC Nov 2018.pdf Draft Oral Tablet 012462 11/2018
Auranofin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Auranofin_cap_18689_RC2-10.pdf Draft Oral Capsule 018689 02/2010
Avanafil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Avanafil_oral tab_202276_RC03-15.pdf Draft Oral Tablet 202276 03/2015
Avatrombopag Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210238.pdf Draft Oral Tablet 210238 09/2019
Axitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Axitinib_tab_202324_RC02-14.pdf Draft Oral Tablet 202324 04/2014
Azacitidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050794.pdf Draft Intravenous, Subcutaneous Powder 050794 05/2021
Azathioprine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azathioprine_tabs_16324_RC09-10.pdf Draft Oral Tablet 016324 09/2010
Azelaic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azelaic Acid Cream 20 NDA 020428 PSG Page RV May 2019.pdf Draft Topical Cream 020428 05/2019
Azelaic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207071.pdf Draft Topical Aerosol, Foam 207071 11/2020
Azelaic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azelaic Acid Gel 15 NDA 021470 PSG Page RV May 2019.pdf Draft Topical Gel 021470 05/2019
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azelastine HCl_nasal metered spray_NDA 022203_RC08-17.pdf Draft Nasal Spray, Metered 022203 10/2017
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azelastine hydrochloride_nasal metered spray_RLD 20114_RC03-17.pdf Draft Nasal Spray, Metered 020114 05/2017
Azelastine Hydrochloride; Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202236.PDF Draft Nasal Spray, Metered 202236 06/2020
Azilsartan Kamedoxomil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azilsartan_Medoxomil_Tab_200796_RC06-12.pdf Draft Oral Tablet 200796 06/2012
Azilsartan Kamedoxomil; Chlorthalidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azilsartan_Kamedoxomil_Chlorthalidone_Tab_202331_RC03-15.pdf Draft Oral Tablet 202331 03/2015
Azithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_tab_50730_RC1-08.pdf Draft Oral Tablet 050711 050730 050784 01/2008
Azithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_ERsusp_50797_RC7-08 .pdf Draft Oral Suspension, Extended Release 050797 07/2008
Azithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_oral for suspension_NDA 050693_RC08-17.pdf Draft Oral For Suspension 050693 10/2017
Azithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_susp_50693_50710_RC12-08.pdf Draft Oral For Suspension 050710 12/2008

Newly Added Guidances since May 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Amlodipine Besylate; Celecoxib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210045.pdf Draft Oral Tablet 210045 05/2021
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf Draft Inhalation Powder 209482 05/2021
Lumateperone Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209500.pdf Draft Oral Capsule 209500 05/2021
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210583.pdf Draft Intravenous Solution 210583 05/2021
Metoclopramide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209388.pdf Draft Nasal Spray, Metered 209388 05/2021
Midazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211321.pdf Draft Nasal Spray 211321 05/2021
Pexidartinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211810.pdf Draft Oral Capsule 211810 05/2021
Pitolisant Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211150.pdf Draft Oral Tablet 211150 05/2021
Quinidine Gluconate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016647.pdf Draft Oral Tablet, Extended Release 016647 05/2021
Trifarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211527.pdf Draft Topical Cream 211527 05/2021
Ubrogepant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211765.pdf Draft Oral Tablet 211765 05/2021
Voxelotor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213137.pdf Draft Oral Tablet 213137 05/2021
Zanubrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213217.pdf Draft Oral Capsule 213217 05/2021

Newly Revised Guidances since May 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Azacitidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050794.pdf Draft Intravenous, Subcutaneous Powder 050794 05/2021
Dasatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021986.pdf Draft Oral Tablet 021986 05/2021
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205434.pdf Draft Nasal Spray, Metered 205434 05/2021
Ledipasvir; Sofosbuvir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205834.pdf Draft Oral Tablet 205834 05/2021
Nitrofurantoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009175.pdf Draft Oral Suspension 009175 05/2021
Pentosan Polysulfate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020193.pdf Draft Oral Capsule 020193 05/2021
Sofosbuvir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204671.pdf Draft Oral Tablet 204671 05/2021
Tofacitinib Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208246.pdf Draft Oral Tablet, Extended Release 208246 05/2021

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