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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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


117 record(s) found for 'B'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Bacitracin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bacitracin_ophthalmic ointment_RLD61212_RV09-16.pdf Draft Ophthalmic Ointment 061212 10/2016
Baclofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Baclofen_tab_72235_72234_RC2-10.pdf Draft Oral Tablet 017851 02/2010
Baclofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021589.pdf Draft Oral Tablet, Orally Disintegrating 021589 11/2019
Baloxavir Marboxil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210854.pdf Draft Oral Tablet 210854 09/2019
Balsalazide Disodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Balsalazide_disodium_tab_022205_RC06-13.pdf Draft Oral Tablet 022205 06/2013
Balsalazide Disodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Balsalazide_cap_20610_RC1-08.pdf Draft Oral Capsule 020610 01/2008
Baricitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207924.pdf Draft Oral Tablet 207924 09/2019
Barium Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Barium sulfate_oral paste_NDA 208844_RC08-17.pdf Draft Oral Paste 208844 10/2017
Barium Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Barium sulfate_oral supension_NDA 208036_RC11-17.pdf Draft Oral Suspension 208036 02/2018
Barium Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Barium sulfate_oral supension_NDA 208143_RC11-17.pdf Draft Oral Suspension 208143 02/2018
Beclomethasone Dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020911.pdf Draft Inhalation Aerosol, Metered 020911 03/2020
Beclomethasone Dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Beclomethasone dipropionate Inhalation Aerosol Metered NDA 207921 PSG Page RC May 2019.pdf Draft Inhalation Aerosol, Metered 207921 05/2019
Beclomethasone Dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Beclomethasone dipropionate_draft_Nasal aerosol metered_RLD 202813_RC07-18.pdf Draft Nasal Aerosol, Metered 202813 07/2018
Beclomethasone Dipropionate Monohydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019389.pdf Draft Nasal Spray, Metered 019389 11/2021
Bedaquiline Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bedaquiline_fumarate_tab_204384_RC11-13.pdf Draft Oral Tablet 204384 11/2013
Bempedoic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211616.pdf Draft Oral Tablet 211616 11/2021
Bempedoic Acid; Ezetimibe https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211617.pdf Draft Oral Tablet 211617 11/2021
Benazepril Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benazepril_HCl_tabs_19851_RC07-10.pdf Draft Oral Tablet 019851 07/2010
Benazepril Hydrochloride; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benazepril HCL and hydrochlorothiazide_oral tablet_20033_RC09-15.pdf Draft Oral Tablet 020033 09/2015
Benoxinate hydrochloride; Fluorescein sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benoxinate hydrochloride; Fluorescein sodium Ophthalmic solution drops 0.25-0.45 NDA 208582 PSG Page RC May 2019.pdf Draft Topical Solution/Drops 208582 05/2019
Benznidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Beznidazole Oral Tablets NDA 209570 RC 09-2018.pdf Draft Oral Tablet 209570 09/2018
Benzonatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzonatate _oral capsule_040749 040627 201209_RV09-15.pdf Draft Oral Capsule 011210 09/2015
Benzoyl Peroxide; Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050819.pdf Draft Topical Gel 050819 11/2019
Benzoyl Peroxide; Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050741.pdf Draft Topical Gel 050741 11/2019
Benzoyl Peroxide; Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050756.pdf Draft Topical Gel 050756 11/2019
Benzoyl Peroxide; Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050557.pdf Draft Topical Gel 050557 11/2019
Benzoyl Peroxide; Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050769.pdf Draft Topical Gel 050769 11/2019
Benzphetamine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzphetamine_HCl_tab_12427_RC5-06.pdf Final Oral Tablet 012427 05/2008
Benztropine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009193.pdf Draft Oral Tablet 009193 09/2019
Benzyl Alcohol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzyl_alcohol_lot_022129_RC12-14.pdf Draft Topical Lotion 022129 12/2014
Berotralstat Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214094.pdf Draft Oral Capsule 214094 08/2022
Besifloxacin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022308.pdf Draft Ophthalmic Suspension/Drops 022308 03/2020
Betamethasone Acetate; Betamethasone Sodium Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone_Acetate;_Sodium_Phosphate_Inj_14602_RC04-10.pdf Draft Injection Suspension, Injectable 014602 04/2010
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_topical Lotion_NDA 01778_RC08-17.pdf Draft Topical Lotion 017781 10/2017
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_topical augmented ointment_NDA 018741_RC11-17.pdf Draft Topical Ointment, Augmented 018741 02/2018
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_draft_Topical spray_RLD 208079_RC07-18.pdf Draft Topical Spray 208079 07/2018
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone Dipropionate_topical cream 0.05_RLD 019137_RC09-16.pdf Draft Topical Cream 019137 10/2016
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_ topical augmented cream_RLD 19555_RC04-16.pdf Draft Topical Cream, Augmented 019555 04/2016
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_topical augmented lotion_RLD 019716_RC01-16.pdf Draft Topical Lotion, Augmented 019716 01/2016
Betamethasone Dipropionate; Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207589.pdf Draft Topical Aerosol, Foam 207589 11/2019
Betamethasone Dipropionate; Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone; Calcipotriene Suspension NDA 022185 RV Feb 2019.pdf Draft Topical Suspension 022185 02/2019
Betamethasone Dipropionate; Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone; Calcipotriene Ointment NDA 021852 RV Feb 2019.pdf Draft Topical Ointment 021852 02/2019
Betamethasone dipropionate;Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone Dipropionate; Clotrimazole Cream NDA 018827 RV Feb 2019.pdf Draft Topical Cream 018827 02/2019
Betamethasone dipropionate;Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone Dipropionate; Clotrimazole Lotion NDA 020010 RV Feb 2019.pdf Draft Topical Lotion 020010 02/2019
Betamethasone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone valerate_topical lotion_RLD 018866_RC01-16.pdf Draft Topical Lotion 018866 01/2016
Betamethasone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone valerate_topical cream_RLD 018861_RC12-16.pdf Draft Topical Cream 018861 12/2016
Betamethasone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone_valerate_aerofoam_20934_RC12-14.pdf Draft Topical Aerosol, Foam 020934 12/2014
Betamethasone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone valerate_topical ointment_RLD 18865_RC10-16.pdf Draft Topical Ointment 018865 10/2016
Betaxolol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/BETAXOLOL HYDROCHLORIDE ophthalmic suspensiondrops NDA 019845 PSG Page RV May 2019.pdf Draft Ophthalmic Solution/Drops 019845 05/2019
Bethanechol Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bethanechol_Chloride_tab_88440_88441_89096_89095_RC9-08.pdf Draft Oral Tablet 006536 09/2008
Betrixaban https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betrixaban_draft_Oral cap_RLD 208383_RC07-18.pdf Draft Oral Capsule 208383 07/2018
Bexarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021055.pdf Draft Oral Capsule 021055 08/2021
Bexarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bexarotene topical gel NDA 021056 RC 2019.pdf Draft Topical Gel 021056 02/2019
Bicalutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bicalutamide_tab_20498_RC5-05.pdf Final Oral Tablet 020498 05/2008
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bictegravir Sodium, Emtricitabin, Tenofovir Alafenamide Fumarate Oral Tablet NDA 210251 page RC May 2019.pdf Draft Oral Tablet 210251 05/2019
Bimatoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bimatoprost_ophthalmic solution drops_NDA 021275_RC11-17.pdf Draft Ophthalmic Solution/Drops 021275 02/2018
Bimatoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bimatoprost_ophthalmic solution drops_NDA 022184_RC11-17.pdf Draft Ophthalmic Solution/Drops 022184 02/2018
Bimatoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bimatoprost_ophthalmic solution drops_NDA 022369_RC11-17.pdf Draft Topical Solution/Drops 022369 02/2018
Binimetinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210498.pdf Draft Oral Tablet 210498 03/2020
Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bisacodyl; PEG3350_ANDA 202217_RC03-17.pdf Draft Oral For Solution, Tablet, Delayed Release 021551 05/2017
Bismuth Subcitrate Potassium; Metronidazole;Tetracycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/BismuthSubcitratePotassiumMetronidazoleTetracyclineHClcap50786RC908.pdf Draft Oral Capsule 050786 09/2008
Bisoprolol Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bisoprolol_Fumarate_tab_19982_RC7-05..pdf Final Oral Tablet 019982 05/2008
Bisoprolol Fumarate; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bisoprolol_Fumarate_HCTZ_tab_20186_RC7-05.pdf Final Oral Tablet 020186 05/2008
Boceprevir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Boceprevir_Cap_202258_RC06-12.pdf Draft Oral Capsule 202258 06/2012
Bortezomib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021602.pdf Draft Intravenous, Subcutaneous Injectable 021602 08/2020
Bosentan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bosentan Tablets for oral suspension NDA 209279 RC Feb 2019.pdf Draft Oral Tablet, For Suspension 209279 02/2019
Bosentan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bosentan_tabs_21290_RC09-10.pdf Draft Oral Tablet 021290 03/2012
Bosutinib Monohydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203341.pdf Draft Oral Tablet 203341 09/2019
Bremelanotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210557.pdf Draft Subcutaneous Solution 210557 03/2021
Brexanolone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211371.pdf Draft Intravenous Solution 211371 06/2020
Brexpiprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brexpiprizole_oral tablet_NDA 205422_RC05-17.pdf Draft Oral Tablet 205422 07/2017
Brigatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brigatinib_draft_Oral tab_RLD 208772_RC09-18.pdf Draft Oral Tablet 208772 09/2018
Brilliant Blue G https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209569.pdf Draft Ophthalmic Solution 209569 12/2021
Brimonidine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate_topical gel_204708_RC09-15.pdf Draft Topical Gel 204708 09/2015
Brimonidine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate ophthalmic solution 0.025 NDA 208144 PSG Page RC May 2019.pdf Draft Ophthalmic Solution/Drops 208144 05/2019
Brimonidine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate_ophthalmic solution_NDA 021770_RV08-17.pdf Draft Ophthalmic Solution/Drops 0.1% 021770 10/2017
Brimonidine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate_ophthalmic solution_NDA 020613_RV08-17.pdf Draft Ophthalmic Solution/Drops 0.2% 020613 10/2017
Brimonidine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine Tartrate_Ophthalmic Solution_NDA 021262_RV07-17.pdf Draft Ophthalmic Solution/Drops 0.15% 021262 07/2017
Brimonidine Tartrate; Brinzolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/BRIMONIDINE TARTRATE BRINZOLAMIDE ophthalmic suspension drops NDA 204251 PSG Page RV May 2019.pdf Draft Ophthalmic Suspension/Drops 204251 05/2019
Brimonidine Tartrate;Timolol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate Timolol MaleateNDA 021398 RC 09-2018.pdf Draft Ophthalmic Solution/Drops 021398 09/2018
Brinzolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/BRINZOLAMIDE ophthalmic suspension drops NDA 020816 PSG Page RV May 2019.pdf Draft Ophthalmic Suspension/Drops 1% 020816 05/2019
Brivaracetam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brivaracetam_oral tablet_NDA 205836_RC05-17.pdf Draft Oral Tablet 205836 07/2017
Bromfenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromfenac sodium_ophthalmic solution_NDA 021664_RV08-17.pdf Draft Ophthalmic Solution/Drops 021664 10/2017
Bromocriptine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromocriptine_ Mesylate_tab_17962_RC11-09.pdf Draft Oral Tablet 017962 11/2009
Bromocriptine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromocriptine_ Mesylate_cap_17962_RC11-09.pdf Draft Oral Capsule 017962 11/2009
Bromocriptine mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromocriptine Mesylate Tablets NDA20866 RC Feb 2019.pdf Draft Oral Tablet 020866 02/2019
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020746.pdf Draft Nasal Spray, Metered 020746 08/2020
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_Inhalation_Sus_20929_RC_09-12.pdf Draft Inhalation Suspension 020929 09/2012
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_inhalation powder_RLD 21949_RC12-16.pdf Draft Inhalation Powder 021949 12/2016
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205613.pdf Draft Rectal Aerosol, Foam 205613 11/2020
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021324.pdf Draft Oral Capsule, Delayed Release 021324 08/2021
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211929.pdf Draft Oral Capsule, Extended Release 211929 03/2020
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_ERTab_203634_RC12-14.pdf Draft Oral Tablet, Extended Release 203634 12/2014
Budesonide; Formoterol Fumarate Dihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide and Formoterol fumarate dihydrate_MDI_021929_RC06-15.pdf Draft Inhalation Aerosol, Metered 021929 06/2015
Bumetanide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bumetanide_tab_74700_RV11-13.pdf Draft Oral Tablet 018225 11/2013
Bupivacaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupivacaine_ liposomal injectable injection_NDA 022496_RC11-17.pdf Draft Injection Injectable, Liposomal 022496 02/2018
Bupivacaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204803.pdf Draft Infiltration Solution, Extended Release 204803 05/2022
Buprenorphine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209819.pdf Draft Subcutaneous Solution, Extended Release 209819 06/2020
Buprenorphine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021306.pdf Draft Transdermal Film, Extended Release 021306 06/2020
Buprenorphine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine hydrochloride_buccal film_NDA 207932_RC11-17.pdf Draft Buccal Film 207932 02/2018
Buprenorphine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine_hydrochloride_SLtab_78633_RV02-14.pdf Draft Sublingual Tablet 020732 02/2014
Buprenorphine Hydrochloride; Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine_HCl;_Naloxone_HCl_subtab_20733_RC5-10.pdf Draft Sublingual Tablet 020733 05/2010
Buprenorphine Hydrochloride; Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine Hcl; Naloxone Hcl_sublingual tablet_RLD 204242_RV12-16.pdf Draft Sublingual Tablet 204242 12/2016
Buprenorphine Hydrochloride; Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine HCL_Naloxone HCL_Buccal Film_205637_RC03-15.pdf Draft Buccal Film 205637 03/2015
Buprenorphine Hydrochloride; Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine HCL; Naloxone HCL_sublingual buccal film_RLD 022410_RV12-16.pdf Draft Buccal, Sublingual Film 022410 12/2016
Bupropion Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HBr_ERtab_22108_RV03-13.pdf Draft Oral Tablet, Extended Release 022108 03/2013
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_ERtab_22497_RC03-13.pdf Draft Oral Tablet, Extended Release 022497 03/2013
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_ERtab_21515_RV03-13.pdf Draft Oral Tablet, Extended Release 021515 03/2013
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_ERtab_20358_20711_RV03-13.pdf Draft Oral Tablet, Extended Release 020358 020711 03/2013
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_tab_18644_RV03-13.pdf Draft Oral Tablet 018644 03/2013
Bupropion Hydrochloride; Naltrexone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200063.pdf Draft Oral Tablet, Extended Release 200063 11/2020
Buspirone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buspirone_tab_18731_RC12-09.pdf Draft Oral Tablet 018731 12/2009
Busulfan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Busulfan_tab_09386_RC7-08.pdf Draft Oral Tablet 009386 07/2009
Butenafine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Butenafine HCl Cream NDA 20524 RV Feb 2019.pdf Draft Topical Cream 020524 02/2019
Butenafine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Butenafine HCl Cream NDA 021307 RV Feb 2019.pdf Draft Topical Cream 021307 02/2019
Butoconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Butoconazole Nitrate Vaginal Cream ANDA 200923 RV Feb 2019.pdf Draft Vaginal Cream 200923 02/2019
Butoconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Butoconazole Nitrate Vaginal Cream NDA 020421 RV Feb 2019.pdf Draft Vaginal Cream 020421 02/2019

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

Newly Revised Guidances since August 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 08/2022
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020114.pdf Draft Nasal Spray, Metered 020114 08/2022
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021621.pdf Draft Oral Tablet, Chewable 021621 08/2022
Dantrolene Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205579.pdf Draft Intravenous For Suspension 205579 08/2022
Ethinyl Estradiol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021490.pdf Draft Oral Tablet 021490 202086 08/2022
Ethinyl Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203667.pdf Draft Oral Tablet 203667 08/2022
Lamotrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020764.pdf Draft Oral Tablet, For Suspension 020764 08/2022
Lanthanum Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021468.pdf Draft Oral Tablet, Chewable 021468 08/2022
Loratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021891.pdf Draft Oral Tablet, Chewable 021891 08/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012541.pdf Draft Injection Injectable 012541 08/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020246.pdf Draft Injection Injectable 020246 08/2022
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210583.pdf Draft Intravenous Solution 210583 08/2022
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021475.pdf Draft Oral Tablet, Chewable 021475 08/2022
Nicotine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020385.pdf Draft Nasal Spray, Metered 020385 08/2022
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021861.pdf Draft Nasal Spray, Metered 021861 08/2022
Oxymetazoline Hydrochloride; Tetracaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208032.pdf Draft Nasal Spray, Metered 208032 08/2022
Prednisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202020.pdf Draft Oral Tablet, Delayed Release 202020 08/2022
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210115.pdf Draft Oral For Suspension 210115 08/2022
Upadacitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211675.pdf Draft Oral Tablet, Extended Release 211675 08/2022
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