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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).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

The Agency is seeking feedback and considers comments to the docket on these guidances. The comments should be submitted to the Docket Management Staff (DMS) under Docket FDA-2007-D-0369-0015. For electronic comments, refer to the website regulations.gov website OR mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please contact the Regulations.gov Help Desk at 1-877-378-5457 (toll free) for assistance regarding submissions.

For additional information on development of generic drug products, please refer to FDA’s webpage on biopharmaceutics guidances.

1GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Commitment Letter) FDA’s webpage on biopharmaceutics guidances.

Total number of currently published PSGs: 1711

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


Newly Added Guidances since February 2018

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Abemaciclib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abemaciclib_draft_Oral tab_RLD 208716_RC09-18.pdf Draft Oral Tablet 208716 09/2018
Acalabrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acalabrutinib Oral Capsules NDA 210259 RC Feb 2019.pdf Draft Oral Capsule 210259 02/2019
Acetaminophen; Caffeine; Dihydrocodeine Bitartratee 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; 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
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
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Albuterol sulfate_draft_Inhalation powder metered_RLD 205636_RC09-18.pdf Draft Inhalation Powder, Metered 205636 09/2018
Alcaftadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alcaftadine_ophthalmic solution_NDA 022134_RC11-17.pdf Draft Ophthalmic Solution, Drops 022134 02/2018
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
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
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
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 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 Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine sulfate_oral tablet_ANDA 200166_RC11-17.pdf Draft Oral Tablet 200166 02/2018
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
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
azelaic acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azelaic acid_draft_Topical foam aerosol_RLD 207071_RC09-18.pdf Draft Topical Aerosol, Foam 207071 09/2018
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/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
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
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 augmented ointment_NDA 018741_RC11-17.pdf Draft Topical Ointment, Augmented 018741 02/2018
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/Bexarotene topical gel NDA 021056 RC 2019.pdf Draft Topical Gel 021056 02/2019
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
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
Brigatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brigatinib_draft_Oral tab_RLD 208772_RC09-18.pdf Draft Oral Tablet 208772 09/2018
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 Drops, Solution 208144 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
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/Budesonide Nasal Spray Metered NDA 020746 PSG Page RC May 2019.pdf Draft Nasal Spray, Metered 020746 05/2019
Bupivacaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupivacaine_ liposomal injectable injection_NDA 022496_RC11-17.pdf Draft Injectable Liposomal, Injection 022496 02/2018
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
Cabozantinib S Malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cabozantinib S-malate_oral capsules_NDA 203756_RC11-17.pdf Draft Oral Capsule 203756 02/2018
Cabozantinib S malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cabozantinib S-Malate_oral tablet_NDA 208692_RC11-17.pdf Draft Oral Tablets 208692 02/2018
Capsaicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Capsaicin_draft_Topical patch_RLD 022395_RC10-18.pdf Draft Topical Patch 022395 10/2018
Chlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorothiazide Oral Suspension NDA 011870 PSG Page RC Feb 2019.pdf Draft Oral Suspension 011870 02/2019
Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpheniramine maleate; Ibuprofen; Pseudoephendrine HCl Tablet 2mg; 200mg; 30mg NDA 021441 PSG Page RC May 2019.pdf Draft Oral Tablet 021441 05/2019
Chlorzoxazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorzoxazone_draft_Oral tab_RLD 011529_RC09-18.pdf Draft Oral Tablet 011529 09/2018
Ciprofloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_draft_Otic susp injec_RLD 207986_RC07-18.pdf Draft Otic Suspension, Injectable 207986 07/2018
Ciprofloxacin hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_HCl_draft_Ophthalmic ointment_RLD_020369_RC09-18.pdf Draft Ophthalmic Ointment 020369 09/2018
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine ophthalmic solution 0.09 NDA 210913 PSG Page RC May 2019.pdf Draft Ophthalmic Drops, Solution 210913 05/2019
Dapagliflozin propanediol;Saxagliptin hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dapagliflozin Propanediol and Saxagliptin HCl Tablets NDA 209091 RC 09-2018.pdf Draft Oral Tablet 209091 09/2018
Daptomycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/DAPTOMYCIN IV infusion powder NDA 209949 & NDA 208385 Page Feb 2019.pdf Draft IV Infusion Powder 209949 208385 02/2019
Deferasirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deferasirox_draft_Oral gran_RLD 207968_RC07-18.pdf Draft Oral Granules 207968 07/2018
Delafloxacin meglumine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Delafloxacin meglumine_draft_Oral tab_RLD 208610_RC09-18.pdf Draft Oral Tablet 208610 09/2018
Desloratadine; Pseudoephedrine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desloratadine_Pseudoephedrine_Oral_Extended_Release_Tablet_NDA_021313_PSG_Page_RC_May_2019.pdf Draft Oral Tablet, Extended Release 021313 05/2019
Desmopressin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desmopressin acetate Sublingual Tablets NDA 022517 PSG Page RC May 2019.pdf Draft Sublingual Tablet 022517 05/2019
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_topical aerosol foam_NDA 021978_RC11-17.pdf Draft Topical Aerosol Foam 021978 02/2018
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_draft_Topical gel_RLD 021844_RC09-18.pdf Draft Topical Gel 021844 09/2018
Deutetrabenazine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deutetrabenazine_draft_Oral tab_RLD 208082_RC09-18.pdf Draft Oral Tablet 208082 09/2018
Dexamethasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone Oral Concentrate Solution ANDA 088252 RC Feb 2019.pdf Draft Oral Concentrate 088252 02/2019
Dexamethasone; Neomycin sulfate; Polymyxin B sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone; Neomycin sulfate; Polymyxin B sulfate_draft_Ophthalmic susp drops_RLD 050023_RC07-18.pdf Draft Ophthalmic Suspension, Drops 050023 07/2018
Diazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diazepam_draft_Oral tab_RLD 013263_RC09-18.pdf Draft Oral Tablet 013263 09/2018
Dichlorphenamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dichlorphenamide_Oral_tablets_NDA_011366_RC_Oct_2018.pdf Draft Oral Tablet 011366 11/2018
Dihydroergotamine mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dihydroergotamine Mesylate Nasal Spray Metered NDA 020148 RC Feb 2019.pdf Draft Nasal Spray, Metered 020148 02/2019
Diltiazem hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diltiazem Hydrochloride oral extended release capsule NDA 019471 RC Feb 2019.pdf Draft Oral Capsule, Extended Release 019471 02/2019
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxepin Hydrochloride_Topical cream_NDA 020126_RC Oct 2018.pdf Draft Topical Cream 020126 11/2018
Doxycycline calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline Calcium Oral Suspension NDA 050480 RC Feb 2019.pdf Draft Oral Suspension Suspension 050480 02/2019
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hyclate_oral tablet_NDA 050783_RC11-17.pdf Draft Oral Tablet 050783 02/2018
Doxylamine succinate; Pyridoxine hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxylamine succinate and pyridoxine hydrochloride oral ER tablet NDA 209661 RC Feb 2019.pdf Draft Oral Capsule, Extended Release 209661 02/2019
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz Lamivudine Tenoforvir Dsisoproxile Funarate Tablets NDA208255 PSG Page RC May 2019.pdf Draft Oral Tablet 208255 05/2019
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz-Lamivudine-Tenofovir Disoproxil Fumarate Oral Tablet NDA 022142 page RC May 2019.pdf Draft Oral Tablet 022142 05/2019
Efinaconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efinaconazole_draft_Topical solution_RLD 203567_RC09-18.pdf Draft Topical Solution 203567 09/2018
Enasidenib mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Enasidenib mesylate_draft_Oral tab_RLD 209606_RC09-18.pdf Draft Oral Tablet 209606 09/2018
Epinephrine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Epinephrine_draft_Intramuscular subcutaneous solution_RLD 207534_RC07-18.pdf Draft Intramuscular, Subcutaneous Solution 207534 07/2018
Eravacycline Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ERAVACYCLINE DIHYDROCHLORIDE POWDER INTRAVENOUS NDA 211109 PSG Page RC May 2019.pdf Draft Intravenous Powder 211109 05/2019
Ertugliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ertugliflozin_Oral tablet_NDA 209803_RC Oct 2018.pdf Draft Oral Tablet 209803 11/2018
Ertugliflozin; Metformin hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ertugliflozin; Metformin Hydrochloride_Oral tablet_NDA 209806_RC Oct 2018.pdf Draft Oral Tablet 209806 11/2018
Ertugliflozin; Sitagliptin phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ertugliflozin; Sitagliptin Phosphateoral_Oral tablet_NDA 209805_RC Oct 2018.pdf Draft Oral Tablet 209805 11/2018
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole magnesium_oral DR suspension_NDA 021957 and 022101_RV11-17.pdf Draft Oral Powder For Suspension, Delayed Release 021957 022101 02/2018
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole magnesium_oral DR capsule pellets_NDA 021153_RV11-17.pdf Draft Oral Capsule/pellets, , Delayed Release 021153 02/2018
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estradiol_Transdermal gel_NDA 022038_RC Oct 2018.pdf Draft Transdermal Gel 022038 11/2018
Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estradiol Levonorgestrel transdermal extended release film NDA 021258 PSG Page RC May 2019.pdf Draft Transdermal Film, Extended Release 021258 05/2019
Estradiol; Norethindrone acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estradiol; Norethindrone acetate_draft_Transdermal film ER_RLD 020870_RC10-18.pdf Draft Transdermal Film, Extended Release 020870 10/2018
Ethinyl estradiol; Norethindrone acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl estradiol; Norethindrone acetate_draft_Oral cap_RLD 204426_RC07-18.pdf Draft Oral Capsule 204426 07/2018
Finafloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Finafloxacin_otic suspension drops_NDA 206307_RC07-18.pdf Draft Otic Suspension, Drops 206307 07/2018
Fish oil; Medium chain triglycerides; Olive oil; Soybean oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fish oil; Medium chain triglycerides; Olive oil; Soybean oil NDA 207648 Feb 2019.pdf Draft Intravenous Emulsion 207648 02/2019
Fluocinolone acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fuocinolone acetonide_topical cream_NDA 012787_RC07-18.pdf Draft Topical Cream 012787 07/2018
Fluocinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluocinonide_topical cream_NDA 019117_RC11-17.pdf Draft Topical Cream 019117 02/2018
Fluticasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone furoate nasal spray metered NDA 022051 PSG Page RC May 2019.pdf Draft Nasal Spray, Metered 022051 05/2019
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone Propionate Inhalation Powder NDA 208798 PSG Page RC May 2019.pdf Draft Inhalation Powder 208798 05/2019
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone Propionate; Salmeterol Xinafoate Inhalation Aerosol Metered NDA 021254 PSG Page RC May 2019.pdf Draft Inhalation Aerosol, Metered 021254 05/2019
Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosnetupitant and Palonosetron Hydrochloride, powder for injection NDA 210493 PSG Page RC May 2019.pdf Draft Intravenous Powder 210493 05/2019
Glecaprevir; Pibrentasvir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glecaprevir Pibrentasvir Oral Tablet NDA 209394 RC 09-2018.pdf Draft Oral Tablet 209394 09/2018
Halcinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Halcinonide topical ointment NDA 017824 PSG Page RC May 2019.pdf Draft Topical Ointment 017824 05/2019
Hydrocortisone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone valerate_topical cream_NDA 017950_RC11-17.pdf Draft Topical Cream 017950 02/2018
Ibuprofen; Pseudoephedrine hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen-Pseudoephedrine Hydrochloride Oral Tablets NDA 019771 RC 09-2018.pdf Draft Oral Tablet 019771 09/2018
Isocarboxazid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isocarboxazid Oral Tablet NDA 011961 RC Feb 2019.pdf Draft Oral Tablet 011961 02/2019
Ivacaftor;Ivacaftor Tezacaftor https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ivacaftor; Tezacaftor Oral Tablet NDA 210491 RC Feb 2019.pdf Draft Oral Tablet 210491 02/2019
Ivermectin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ivermectin topical lotion NDA 202736 RC 09-2018.pdf Draft Topical Lotion 202736 09/2018
Ixazomib Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ixazomibe citrate_oral capsule_NDA 208462_RC11-17.pdf Draft Oral Capsule 208462 02/2018
Ketoconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ketoconazole_oral tablet_ANDA 075273_RC11-17.pdf Draft Oral Tablet 018533 02/2018
Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamivudine-Tenofovir Disoproxil Fumarate Oral Tablet NDA 022141 PSG page RC May 2019.pdf Draft Oral Tablet 022141 05/2019
Lamotrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamotrigine_draft_Oral tab disintegrating_RLD 022251_RC09-18.pdf Draft Oral Tablet, Disintegrating 022251 09/2018
Latanoprostene bunod https://www.accessdata.fda.gov/drugsatfda_docs/psg/Latanoprostene Bunod_Ophthalmic solution drops_NDA 207795_RC Oct 2018.pdf Draft Ophthalmic Solution, Drops 207795 11/2018
Letermovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Letermovir_IV_infusion_solution_NDA_209940_RC_Oct_2018.pdf Draft IV Infusion, Subcutaneous Solution 209940 11/2018
Letermovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Letermovir_Oral tablet_NDA 209939_RC Oct 2018.pdf Draft Oral Tablet 209939 11/2018
Letrozole;Ribociclib Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Letrozole and Ribociclib Succinate Copackaged Oral Tablet NDA 209935 RC Feb 2019.pdf Draft Oral Tablet 209935 02/2019
Levetiracetam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levetiracetam_draft_Oral Suspension tabs_RLD 207958_RC02-18.pdf Draft Oral Suspension Tablets 207958 02/2018
Levocetirizine Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levocetirizine dihydrochloride_draft_Oral tabs_RLD 209089_RC02-18.pdf Draft Oral Tablets 209089 02/2018
Levothyroxine sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levothyroxine_Sodium capsules_NDA 021924_RC Oct 2018.pdf Draft Oral Capsules 021924 11/2018
Lifitegrast https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lifitegrast_Ophthalmic solution drops_NDA 208073_RC Oct 2018.pdf Draft Ophthalmic Drops, Solution 208073 11/2018
Linaclotide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Linaclotide-Capsule-NDA-202811-Page-RC-12-2018.pdf Draft Oral Capsules 202811 12/2018
Loratadine; Pseudoephedrine sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loratadine Pseudoephedrine Oral Extended Release Tablet NDA 020470 RC Feb 2019.pdf Draft Oral Tablet, Extended Release 020470 02/2019
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loteprednol Etabonate_draft_Ophthalmic drops susp 0.02_RLD 020803_RC02-18.pdf Draft Ophthalmic Drops, Suspension 0.020% 020803 02/2018
Loteprednol etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loteprednol etabonate_draft_Ophthalmic ointment_RLD 200738_RC07-18.pdf Draft Ophthalmic Ointment 200738 07/2018
Luliconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Luliconazole_draft_Topical cream_RLD 204153_RC09-18.pdf Draft Topical Cream 204153 09/2018
Macimorelin acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Macimorelin Acetate_Oral solution_NDA 205598_RC Oct 2018.pdf Draft Oral Solution 205598 11/2018
Mebendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mebendazole_draft_Oral tab chewable_RLD 208398_RC02-18.pdf Draft Oral Tablet, Chewable 208398 02/2018
Mecamylamine hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mecamylamine hydrochloride_draft_Oral tab_RLD 010251_RC07-18.pdf Draft Oral Tablet 010251 07/2018
Menthol; Methyl salicylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Menthol; Methyl Salicylate_draft_Topical patch_RLD 22029_RC10-18.pdf Draft Topical Patch 022029 10/2018
Methscopolamine bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methscopolamine bromide_draft_Oral tab_RLD 040624_RC07-18.pdf Draft Oral Tablet 040624 07/2018
Methsuximide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methsuximide Oral Capsules NDA 010596 RC Feb 2019.pdf Draft Oral Capsule 010596 02/2019
Methylphenidate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylphenidate_draft_Orally disintegrating tab ER_RLD 205489_RC07-18.pdf Draft Oral Tablets, Extended Release, Orally Disintegrating 205489 07/2018
Metoprolol succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metoprolol succinate_Oral extended release capsule_NDA 210428_RC Nov 2018.pdf Draft Oral Capsule, Extended Release 210428 11/2018
Metyrosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metyrosine_draft_Oral cap_RLD 017871_RC07-18.pdf Draft Oral Capsule 017871 07/2018
Midostaurin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Midostaurin_draft_Oral cap_RLD 207997_RC09-18.pdf Draft Oral Capsules 207997 09/2018
Miltefosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miltefosine_draft_Oral cap_RLD 204684_RC09-18.pdf Draft Oral Capsules 204684 09/2018
Morphine sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine sulfate_draft_Oral cap_RLD 208603_RC09-18.pdf Draft Oral Tablet, Extended Release 208603 09/2018
Moxifloxacin hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Moxifloxacin hydrochloride_draft_Ophthalmic solution drops_RLD 021598_RC07-18.pdf Draft Ophthalmic Solution, Drops 021598 07/2018
Naldemedine Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naldemedine tosylate_oral tablet_NDA 208854_RC11-17.pdf Draft Oral Tablet 208854 02/2018
Naproxen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naproxen Oral Suspension NDA 018965 PSG Page RC May 2019.pdf Draft Oral Suspension 018965 05/2019
Naproxen Sodium; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naproxen sodium; Pseudoephedrine HCl_oral ER tablet_NDA 021076_RC11-17.pdf Draft Oral Tablet, Extended Release 021076 02/2018
Nebivolol hydrochloride; Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nebivolol HCl; Valsartan_oral tablet_NDA 206302_RC07-18.pdf Draft Oral Tablet 206302 07/2018
Neratinib maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Neratinib Maleat Oral Tablets NDA 208051 RC 09-2018.pdf Draft Oral Tablet 208051 09/2018
Netarsudil dimesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Netarsudil Dimesylate_Ophthalmic solution drops_NDA 208254_RC Oct 2018.pdf Draft Ophthalmic Drops, Solution 208254 11/2018
Nimodipine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nimodipine_oral capsule_NDA 018869_RC07-18.pdf Draft Oral Capsule 018869 07/2018
Niraparib Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Niraparib tosylate_oral capsule_NDA 208447_RC11-17.pdf Draft Oral Capsule 208447 02/2018
Nitazoxanide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitazoxanide_Oral suspension_NDA 021498_RC Oct 2018.pdf Draft Oral Suspension 021498 11/2018
Nitisinone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitisinone_oral tablet_NDA 209449_RC07-18.pdf Draft Oral Tablet 209449 07/2018
Olaparib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olaparib Oral Tablet NDA 208558 RC 09-2018.pdf Draft Oral Tablet 208558 09/2018
Olive Oil; Soybean Oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olive oil; Soybean Oil injectable injection RLD 204508 RC 09-2018.pdf Draft Injection Injectable 204508 09/2018
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olopatadine hydrochloride_ophthalmic solution_NDA 206276_RC11-17.pdf Draft Ophthalmic Drops, Solution 206276 02/2018
Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole_orally disintegrating DR tablet_NDA 209400_RC07-18.pdf Draft Oral Tablet, Delayed Release, Orally Disintegrating 209400 07/2018
Omeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole magnesium oral delayed release suspension NDA 022056 PSG Page RC May 2019.pdf Draft Oral Granules, Delayed Release 022056 05/2019
Oxybutynin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxybutynin transdermal extended release film NDA 021351 PSG Page RV10-18.pdf Draft Transdermal Film, Extended Release 021351 10/2018
Oxycodone hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone hydrochloride oral tablet NDA 209777 RC 09-2018.pdf Draft Oral Tablet 209777 09/2018
Ozenoxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ozenoxacin topical cream NDA 208945 RC 2019.pdf Draft Topical Cream 208945 02/2019
Paroxetine mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Paroxetine Mesylate Oral Tablets NDA NDA 021299 RC Feb 2019.pdf Draft Oral Tablet 021299 02/2019
Penciclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Penciclovir topical cream NDA 020629 RC 09-2018.pdf Draft Topical Cream 020629 09/2018
Penicillamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Penicillamine_Oral Tablet_NDA 19854_RC Oct 2018.pdf Draft Oral Tablet 019854 11/2018
Pilocarpine hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PILOCARPINE HYDROCHLORIDE ophthalmic solution NDA 200890 RC 09-2018.pdf Draft Ophthalmic Solution 200890 09/2018
Pitavastatin magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pitavastatin Magnesium Oral Tablets NDA 208379 RC 09-2018.pdf Draft Oral Tablet 208379 09/2018
Pitavastatin sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pitavastatin Sodium Oral Tablet NDA 209875 RC 09-2018.pdf Draft Oral Tablet 209875 09/2018
Plecanatide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Plecanatide_Oral tablet_NDA 208745_RC Oct 2018.pdf Draft Oral Tablet 208745 11/2018
Potassium Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Potassium citrate_oral ER tablet_NDA 19071_RV11-17.pdf Draft Oral Tablet, Extended Release 019071 02/2018
Prasterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Prasterone_vaginal insert_NDA 208470_RC11-17.pdf Draft Vaginal Insert 208470 02/2018
Pregabalin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pregabalin oral extended release tablet NDA 209501 RC 09-2018.pdf Draft Oral Tablet, Extended Release 209501 09/2018
Primidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Primidone Tablets NDA 009170 PSG Page RC May 2019.pdf Draft Oral Tablet 009170 05/2019
Raltegravir Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Raltgravir Potassium Oral Tablets NDA 022145 RV 09-2018.pdf Draft Oral Tablet 022145 09/2018
Reserpine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Reserpine_Oral tablets_NDA 009838_RC Oct 2018.pdf Draft Oral Tablet 009838 11/2018
Ribociclib succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ribociclib Succinate_Oral tablet_NDA 209092_RC Oct 2018.pdf Draft Oral Tablet 209092 11/2018
Rifapentine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rifapentine_oral tablet_NDA 021024_RC07-18.pdf Draft Oral Tablet 021024 07/2018
Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ritonavir_oral powder_NDA 209512_RC07-18.pdf Draft Oral Capsule 209512 05/2018
Rivastigmine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rivastigmine_transdermal extended release film_NDA 022083_RV10-18.pdf Draft Transdermal Film, Extended Release 022083 10/2018
Rotigotine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rotigotine_transdermal extended release film_NDA 021829_RV10-18.pdf Draft Transdermal Film, Extended Release 021829 10/2018
Rucaparib Camsylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Rucaparib camsylate_oral tablet_NDA 209115_RC11-17.pdf Draft Oral Tablet 209115 02/2018
Safinamide Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Safinamide mesylate_oral tablet_NDA 207145_RC11-17.pdf Draft Oral Tablet 207145 02/2018
Secnidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Secnidazole Oral Granules NDA 209363 RC 09-2018.pdf Draft Oral Granules 209363 09/2018
Simvastatin; Sitagliptin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Simvastatin; Sitagliptin phosphate_oral tablet_NDA 202343_RC11-17.pdf Draft Oral Tablet 202343 02/2018
Sodium Polystyrene Sulfonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sodium polystyrene sulfonate_oralrectal suspension_ANDA 087859_RC07-18.pdf Draft Oral/Rectal Suspension 087859 07/2018
Sofosbuvir; Velpatasvir; Voxilaprevir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sofosbuvir Velpatasvir Voxilaprevir Oral Tablets NDA 209195 RC 09-2018.pdf Draft Oral Tablet 209195 09/2018
Soybean Oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Soybean oil_injectable injection_NDA 019531_RC11-17.pdf Draft Injectable Injection 019531 02/2018
Soybean Oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Soybean oil_injectable injection_NDA 020248, 018449, 017643_RC11-17.pdf Draft Injectable Injection 017643 018449 020248 02/2018
Spironolactone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Spironolactone Suspension Oral NDA 209478 RC 09-2018.pdf Draft Oral Suspension 209478 09/2018
Succimer https://www.accessdata.fda.gov/drugsatfda_docs/psg/Succimer Oral Capsule 100 mg NDA 019998 RC Feb 2019.pdf Draft Oral Capsules 019998 02/2019
Sulfamethoxazole; Trimethoprim https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sulfamethoxazole; Trimethoprim_oral tablet_NDA 017377_RV11-17.pdf Draft Oral Tablet 017377 02/2018
Sulfur Hexafluoride Lipid Type A Microspheres https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sulfur hexafluoridelipid Type-A microspheresuspension 203684RC 09-2018.pdf Draft Intravenous Suspension 203684 09/2018
Talc https://www.accessdata.fda.gov/drugsatfda_docs/psg/Talc intrapleural aerosol NDA 020587 RC 09-2018.pdf Draft Inhalation Aerosol, Metered 020587 09/2018
Tavaborole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tavaborole topical solution NDA 204427 RC 09-2018.pdf Draft Topical Solution 204427 09/2018
Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_transdermal extended release film_NDA 020489_RV10-18.pdf Draft Transdermal Film, Extended Release 020489 10/2018
Thiothixene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Thiothixene_Oral capsule_NDA 016584_RC Oct 2018.pdf Draft Oral Capsule 016584 11/2018
Timolol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Timolol Maleate Ophthalmic Solution NDA 018086 PSG Page RC May 2019.pdf Draft Ophthalmic Drops, Solution 018086 05/2019
Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tobramycin ophthalmic ointment 0.3 NDA 050555 PSG Page RC May 2019.pdf Draft Ophthalmic Ointment 050555 05/2019
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_dental paste_NDA 012097_RV11-17.pdf Draft Dental Paste 012097 02/2018
Triamcinolone acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_intravitreal injectable_NDA 022048_RC07-18.pdf Draft Intravitreal Injectable 022048 07/2018
Valbenazine tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Valbenazine tosylate_oral capsule_NDA 209241_RC07-18.pdf Draft Oral Capsule 209241 07/2018

Newly Revised Guidances since February 2018

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
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
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; 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; 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
Acetazolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetazolamide Oral Tablet NDA 008943 RV 09-2018.pdf Draft Oral Tablets 008943 09/2018
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Adapalene_Topical lotion_NDA 022502_RV Nov 2018.pdf Draft Topical Lotion 022502 11/2018
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Adapalene_Topical cream_NDA 020748_RV Nov 2018.pdf Draft Topical Cream 020748 11/2018
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Adapalene_Topical gel_NDA 20380_RV Oct 2018.pdf Draft Topical Gel 020380 11/2018
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Adapalene_Topical gel_NDA 021753_RV Nov 2018.pdf Draft Topical Gel 021753 11/2018
Adapalene; Benzoyl Peroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Adapalene_Benzoyl_Peroxide_Gel_0.1_2.5_NDA_22320_RV_Nov_2018.pdf Draft Topical Gel 022320 11/2018
Adapalene; Benzoyl Peroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Adapalene_Benzoyl_Peroxide_Gel_NDA_207917_RV_Nov_2018.pdf Draft Topical Gel 207917 11/2018
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; 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
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/Azelaic Acid Gel 15 NDA 021470 PSG Page RV May 2019.pdf Draft Topical Gel 021470 05/2019
Azelastine Hydrochloride; Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azelastine hydrochloride; Fluticasone propionate nasal metered spray NDA 202236 PSG Page RV 02-2019.pdf Draft Nasal Spray, Metered 202236 02/2019
Benzoyl Peroxide;Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzoyl_Clindamycin_Gel_25_12_NDA_050819_RV_Nov_2018.pdf Draft Topical Gel 050819 11/2018
Benzoyl Peroxide;Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzoyl_Clindomycin_Gel_5_1_NDA_050741_RV_Nov_2018.pdf Draft Topical Gel 050741 11/2018
Benzoyl Peroxide;Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzoyl_Clindamycin_Gel_5_1_NDA_050756_RV_Nov_2018.pdf Draft Topical Gel 050756 11/2018
Benzoyl Peroxide;Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzoyl_Peroxide_Erythromycin_Gel_5_3_NDA_50557_RV_Nov_2018.pdf Draft Topical Gel 050557 11/2018
Benzoyl Peroxide;Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzoyl_Peroxide_Erythromycin_Topical_Gel_5_3_50769_RV_Nov_2018.pdf Draft Topical Gel 050769 11/2018
Betamethasone dipropionate;Calcipotriene Hydrate 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;Calcipotriene Hydrate 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;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 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
Betaxolol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/BETAXOLOL HYDROCHLORIDE ophthalmic suspensiondrops NDA 019845 PSG Page RV May 2019.pdf Draft Ophthalmic Suspension, Drops 019845 05/2019
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 Drops, Suspension 204251 05/2019
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
Buprenorphine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine_transdermal extended release film_NDA 021306_RV10-18.pdf Draft Transdermal Film, Extended Release 021306 10/2018
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
Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcipotriene Topical Emulsion Cream NDA 020554 RV Feb 2019.pdf Draft Topical Cream 020554 02/2019
Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcipotriene Topical Ointment NDA 020273 RV Feb 2019.pdf Draft Topical Ointment 020273 02/2019
Ceritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ceritinib Oral Capsule NDA 205755 RV Feb 2019.pdf Draft Oral Capsule 205755 02/2019
Chlorpromazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpromazine Hydrochloride Oral Tablet ANDA 84114 RV 09-2018.pdf Draft Oral Tablet 084112 084114 09/2018
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Suspension NDA 019824 RV Feb 2019.pdf Draft Topical Suspension 019824 02/2019
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Cream NDA 018748 RV Feb 2019.pdf Draft Topical Cream 018748 02/2019
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Gel NDA 020519 RV Feb 2019.pdf Draft Topical Gel 020519 02/2019
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin phosphate_Topical gel_NDA 050615_RV Nov 2018.pdf Draft Topical Gel 050615 11/2018
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin Phosphate_Topical gel_NDA 50782 RV Nov 2018.pdf Draft Topical Gel 050782 11/2018
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin Phosphate_Topical lotion_NDA 050600_RV Nov 2018.pdf Draft Topical Lotion 050600 11/2018
Clindamycin Phosphate;Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin Phosphate;Tretinoin Gel gel 1.2; 0.025 PSG Page RV Nov 2018.pdf Draft Topical Gel 050802 050803 11/2018
Clonidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonidine transdermal extended release film NDA 018891 PSG Page RV10-18.pdf Draft Transdermal Film, Extended Release 018891 10/2018
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Cream NDA 018052 RV Feb 2019.pdf Draft Vaginal Cream 018052 02/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Cream NDA 020574 RV Feb 2019.pdf Draft Vaginal Cream 020574 02/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Tablet NDA 017717 RV Feb 2019.pdf Draft Vaginal Tablet 017717 02/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Tablet NDA 020525 RV Feb 2019.pdf Draft Vaginal Tablet 020525 02/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Topical Solution NDA 018181 RV Feb 2019.pdf Draft Topical Solution 018181 02/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Topical Cream ANDA 072640 RV Feb 2019.pdf Draft Topical Cream 072640 02/2019
Crisaborole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Crisaborole-NDA-207695.pdf Draft Topical Ointment 207695 02/2019
Cysteamine Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cysteamine bitartrate_oral DR capsule_NDA 203389_RV11-17.pdf Draft Oral Capsule, Delayed Release 203389 02/2018
Daclatasvir Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Daclatasvir dihydrochloride_oral tablet_NDA 206843_RV11-17.pdf Draft Oral Tablet 206843 02/2018
Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dapsone_Topical gel_NDA 207154_RV Nov 2018.pdf Draft Topical Gel 207154 11/2018
Dexlansoprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexlansoprazole_orally disintegrating DR tablet_NDA 208056_RV11-17.pdf Draft Oral Tablet, Delayed Release, Orally Disintegrating 208056 02/2018
Dexlansoprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexlansoprazole_oral DR capsule_NDA 022287_RV11-17.pdf Draft Oral Capsule, Delayed Release 022287 02/2018
Diclofenac Epolamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac Epolamine_draft_Topical patch_RLD 21234_RC10-18.pdf Draft Topical Patch 021234 10/2018
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac Sodium_draft_Topical gel_RLD 22122_RC07-18.pdf Draft Topical Gel 022122 07/2018
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac Sodium Topical Gel NDA 021005 RV Feb 2019.pdf Draft Topical Gel 021005 02/2019
Donepezil Hydrochloride;Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Donepezil Hydrochloride; Memantine Hydrochloride_draft_Oral cap ER_RLD 206439_RC07-18.pdf Draft Oral Capsule 206439 07/2018
Doxorubicin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxorubicin Hydrochloride_draft_Injection injec lipo_RLD 50718_RC09-18.pdf Draft Injection Injectable, Liposomal 050718 09/2018
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hyclate_oral DR tablet_NDA 050795_RV03-18.pdf Draft Oral Tablet, Delayed Release 050795 03/2018
Econazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Econazole Nitrate Topical Cream NDA 018751 RV Feb 2019.pdf Draft Topical Cream 018751 02/2019
Esomeprazole Strontium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole Strontium_draft_Oral cap DR_RLD 202342_RC07-18.pdf Draft Oral Capsule, Delayed Release 202342 07/2018
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estradiol_draft_Transdermal film ER_RLD 19081_RC10-18.pdf Draft Transdermal Film, Extended Release 019081 10/2018
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estradiol_draft_Transdermal film ER_RLD 20375 21674_RC10-18.pdf Draft Transdermal Film, Extended Release 020375 021674 10/2018
Ethinyl Estradiol;Norelgestromin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl Estradiol; Norelgestromin_draft_Transdermal film ER_RLD 21180_RC10-18.pdf Draft Transdermal Film, Extended Release 200910 10/2018
Ethosuximide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethosuximide_draft_Oral cap_RLD 012380_RC07-18.pdf Draft Oral Capsule 012380 07/2018
Everolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/Everolimus_draft_Oral tab_RLD 22334_RC11-18.pdf Draft Oral Tablet 022334 11/2018
Felbamate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Felbamate_oral suspension_NDA 020189_RV11-17.pdf Draft Oral Suspension 020189 02/2018
Felbamate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Felbamate_oral tablet_NDA 020189_RV11-17.pdf Draft Oral Tablet 020189 02/2018
Fentanyl https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fentanyl_transdermal extended release film_NDA 019813_RV10-18.pdf Draft Transdermal Film, Extended Release 019813 10/2018
Fluconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluconazole_oral tablet_NDA 019949_RV11-17.pdf Draft Oral Tablet 019949 02/2018
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorouracil Topical Cream NDA 016988 RV Feb 2019.pdf Draft Topical Cream 016988 02/2019
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorouracil Topical Cream NDA 020985 RV Feb 2019.pdf Draft Topical Cream 020985 02/2019
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorouracil Topical Cream NDA 016831 RV Feb 2019.pdf Draft Topical Cream 016831 02/2019
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone propionate metered inhalation aerosol NDA 021433 RV 07-2018.pdf Draft Inhalation Aerosol, Metered 021433 07/2018
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone propionate nasal spray NDA 020121 RV 02-2019.pdf Draft Nasal Spray, Metered 020121 02/2019
Fosfomycin Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosfomycin Tromethamine Oral Solution NDA 050717 PSG Page RV May 2019.pdf Draft Oral Suspension 050717 05/2019
Gatifloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Gatifloxacin_ophthalmic solution drops_NDA 021493_RV11-17.pdf Draft Ophthalmic Solution 0.3% 021493 02/2018
Gentamicin Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Gentamicin sulfate_ophthalmic solution drops_NDA 050039_RV11-17.pdf Draft Ophthalmic Solution 050039 02/2018
Glatiramer Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glatiramer acetate_subcutaneous Injection_NDA 020622_RV07-18.pdf Draft Subcutaneous Injection 020622 07/2018
Granisetron https://www.accessdata.fda.gov/drugsatfda_docs/psg/Granisetron_transdermal extended release film_NDA 022198_RV10-18.pdf Draft Transdermal Film, Extended Release 022198 10/2018
Haloperidol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Haloperidol Oral Tablets NDA 015921 RV Feb 2019.pdf Draft Oral Tablet 015921 02/2019
Hydrocodone Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocodone bitartrate_oral ER tablet_NDA 206627_RV07-18.pdf Draft Oral Tablet, Extended Release 206627 07/2018
Imiquimod https://www.accessdata.fda.gov/drugsatfda_docs/psg/Imiquimod Topical Cream NDA 020723 RV Feb 2019.pdf Draft Topical Cream 020723 02/2019
Isosorbide Dinitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isosorbide Dinitrate_Oral tablet_NDA 012093_RV Nov 2018.pdf Draft Oral Tablet 012093 11/2018
Ivacaftor;Lumacaftor https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ivacaftor-Lumacaftor Oral Tablet NDA 206038 RV Feb 2019.pdf Draft Oral Tablet 206038 02/2019
Ivermectin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ivermectin Topical Cream 1 NDA 206255 PSG Page RV May 2019.pdf Draft Topical Cream 206255 05/2019
Ketoconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ketoconazole Topical Cream NDA 019084 RV Feb 2019.pdf Draft Topical Cream 019084 02/2019
Ketorolac Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ketorolac tromethamine_nasal metered spray_NDA 022382_RV11-17.pdf Draft Nasal Spray, Metered 022382 02/2018
Lansoprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lansoprazole_draft_Oral tab delayed-release OD_RLD 21428_RC02-18.pdf Draft Oral Tablet, Delayed Release, Orally Disintegrating 021428 02/2018
Leucovorin Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Leucovorin Calcium_draft_Oral tab_RLD 18342_RC07-18.pdf Draft Oral Tablet 018342 07/2018
Leuprolide Acetate; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Leuprolide_acetate_Norethindrone_acetate_NDA_203696_ RC11-17.pdf Draft Oral / Intramuscular Tablet, Injectable Depot 203696 02/2018
Lidocaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lidocaine_draft_Topical patch_RLD 020612_RC10-18.pdf Draft Topical Patch 020612 10/2018
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loteprednol Etabonate_draft_Ophthalmic drops susp_RLD 20583_RC02-18.pdf Draft Ophthalmic Drops, Suspension 020583 02/2018
Metaxalone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metaxalone_draft_Oral tab_RLD 13217_RC11-18.pdf Draft Oral Tablet 013217 11/2018
Methylphenidate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylphenidate_draft_Transdermal film ER_RLD 21514_RC10-18.pdf Draft Transdermal Film, Extended Release 021514 10/2018
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylphenidate Hydrochloride_draft_Oral tab ER_RLD 21121_RC07-18.pdf Draft Oral Tablet, Extended Release 021121 07/2018
Methylprednisolone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylprednisolone Oral Tablet NDA 11153 PSG Page RV May 2019.pdf Draft Oral Tablet 011153 05/2019
Miconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miconazole_Buccal_Tablet_50mg_NDA_22404_RV_Feb_2019.pdf Draft Buccal Tablet 022404 02/2019
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone furoate nasal spray NDA 020762 RV 02-2019.pdf Draft Nasal Spray, Metered 020762 02/2019
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine sulfate_draft_Oral tab ER_RLD 206544_RC09-18.pdf Draft Oral Tablet, Extended Release 206544 09/2018
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine sulfate_oral ER capsule_NDA 020616_RV11-17.pdf Draft Oral Capsule, Extended Release 020616 02/2018
Morphine Sulfate;Naltrexone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine sulfate; Naltrexone HCL_oral ER capsule_NDA 022321_RV07-18.pdf Draft Oral Capsule, Extended Release 022321 07/2018
Mycophenolic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mycophenolic Acid_draft_Oral tab DR_RLD 50791_RC11-18.pdf Draft Oral Tablet, Delayed Release 050791 11/2018
Naloxegol Oxalate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naloxegol oxalate_oral tablet_NDA 204760_RV11-17.pdf Draft Oral Tablet 204760 02/2018
Nicotine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nicotine_transdermal _NDA 020076 and NDA 020165_RV10-18.pdf Draft Transdermal Film, Extended Release 020076 020165 10/2018
Nicotine Polacrilex https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nicotine Polacrilex Troche Lozenge NDA 21330 RV 09-2018.pdf Draft Oral Troche, Lozenge 021330 09/2018
Nisoldipine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nisoldipine oral extended release tablet ANDA 079051 RV 09-2018.pdf Draft Oral Tablet, Extended Release 079051 09/2018
Nitroglycerin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitroglycerin_transdermal extended release film_NDA 020145_RV10-18.pdf Draft Transdermal Film, Extended Release 020145 10/2018
Nitroglycerin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Nitroglycerin_transdermal extended release film_NDA 020144_RV10-18.pdf Draft Transdermal Film, Extended Release 020144 10/2018
Oxiconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxiconazole Nitrate Cream NDA 019828 RV Feb 2019.pdf Draft Topical Cream 019828 02/2019
Oxiconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxiconazole Nitrate Lotion NDA 020209 RV Feb 2019.pdf Draft Topical Lotion 020209 02/2019
Oxybutynin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxybutynin_transdermal extended release film_NDA 202211_RV10-18.pdf Draft Transdermal Film, Extended Release 202211 10/2018
Oxycodone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone oral ER capsule NDA 208090 RV 09-2018.pdf Draft Oral Capsule, Extended Release 208090 09/2018
Oxycodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Oxycodone hydrochloride_oral ER tablet_NDA 022272_RV07-18.pdf Draft Oral Tablet, Extended Release 022272 07/2018
Pantoprazole Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Pantoprazole sodium_oral DR suspension_NDA 022020_RV11-17.pdf Draft Oral Powder For Suspension, Delayed Release 022020 02/2018
Perflutren https://www.accessdata.fda.gov/drugsatfda_docs/psg/Perflutren Liposomal Injection RLD 021064 RC 09-2018 .pdf Draft Intravenous Injectable 021064 09/2018
Prednisolone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Prednisolone acetate Ophthalmic suspension RLD 017011 PSG Page RV May 2019.pdf Draft Ophthalmic Suspension, Drops 017011 05/2019
Scopolamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Scopolamine_transdermal extended release film_NDA 017874_RV10-18.pdf Draft Transdermal Film, Extended Release 017874 10/2018
Selegiline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Selegiline_transdermal extended release film_NDA 021336_RV10-18.pdf Draft Transdermal Film, Extended Release 021336 10/2018
Sumatriptan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sumatriptan_Nasal spray_NDA 020626_RV Nov 2018.pdf Draft Nasal Spray 020626 11/2018
Terbinafine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terbinafine Hydrochloride Topical Cream NDA 020980 RV Feb 2019.pdf Draft Topical Cream 020980 02/2019
Ticagrelor https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ticagrelor_oral tablet_NDA 022433_RV07-18.pdf Draft Oral Tablet 022433 07/2018
Tofacitinib Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tofacitinib Citrate Oral Tablet NDA 203214 PSG Page RV May 2019.pdf Draft Oral Tablet 203214 05/2019
Treprostinil Diolamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Treprostinil diolamine oral extended release tablet NDA 203496 RV Feb 2019.pdf Draft Oral Tablet, Extended Release 203496 02/2019
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin_Topical gel 0.1_NDA 020475_RV Nov 2018.pdf Draft Topical Gel 0.1% 020475 11/2018
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin_Topical gel 0.4_NDA 020475_RV Nov 2018.pdf Draft Topical Gel 0.04% 020475 11/2018
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin_Topical cream_NDA 017340_RV Nov 2018.pdf Draft Topical Cream 017340 11/2018
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin_Topical cream_NDA 017522_RV Nov 2018.pdf Draft Topical Cream 017522 11/2018
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin_Topical cream_NDA 019049_RV Nov 2018.pdf Draft Topical Cream 019049 11/2018
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin Topical Cream ANDA 090098 RV Feb 2019.pdf Draft Topical Cream 090098 02/2019
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin_Topical gel_NDA 017579_RV Nov 2018.pdf Draft Topical Gel 017579 11/2018
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin_Topical gel_NDA 017955_RV Nov 2018.pdf Draft Topical Gel 017955 11/2018
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin_Topical gel_NDA 022070_RV Nov 2018.pdf Draft Topical Gel 022070 11/2018
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide nasal spray NDA 020468 RV Feb 2019.pdf Draft Nasal Spray, Metered 020468 02/2019
Triamterene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamterene_Oral capsule_NDA 013174_RV Oct 2018.pdf Draft Oral Capsule 013174 11/2018
Zolmitriptan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Zolmitriptan_Nasal spray_NDA 021450_RV Oct 2018.pdf Draft Nasal Spray 021450 11/2018

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