Product-Specific Recommendations 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 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: 
To further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing  the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.  
These recommendations are published in an incremental manner and listed below in alphabetical order according to RLD’s name. The most recently published recommendations (new and revised) are listed below.
The Agency is seeking feedback and considers comments to the docket on these recommendations. The comments should be submitted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. For electronic comments, refer to the website http://www.regulations.gov 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 refer to http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064964.htm  


Bioequivalence Recommendations for Specific Products Arranged by Active Ingredient [Total count 1362]
A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

Newly Added Recommendations since June 30, 2015 (41 New; 18 Revisions) updated 10/30/2015

Active Ingredient
(link to Specific Guidance)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date Recommended

 Aclidinium bromide (PDF - 97KB)

 Draft  inhalation powder, metered 202450 9/2015

 Acyclovir (PDF - 47KB)

 Draft  Oral

 Tablet, buccal

203791 9/2015

 Aminocaproic acid (PDF - 39KB)

 Draft  Oral Tablet 015197 9/2015

 Apremilast (PDF - 23KB)

Draft Oral Tablet 205437 9/2015

Benazepril HCl; Hydrochlorothiazide (PDF - 41KB)

Draft Oral Tablet 20033 9/2015

Brimonidine tartrate (PDF - 114KB)

Draft Topical Gel 204708 9/2015

Bupropion HCl; Naltrexone HCl (PDF - 46KB) 

Draft Oral Tablet, Extended Release 200063 9/2015

 Carbidopa; levodopa (PDF - 42KB)

Draft Oral Capsule, Extended Release 203312 9/2015

 Ceritinib (PDF - 38KB)

Draft  Oral Capsule 205755 9/2015

 Clobetasol propionate (PDF - 39KB)

Draft Topical Aerosol, foam 22013 9/2015

  Clomipramine HCl (PDF - 41KB)

Draft Oral Capsule 019906 9/2015

 Clonidine HCl (PDF - 42KB)

Draft Oral Tablet, Extended Release 022331 9/2015

 Cobicistat (PDF - 41KB)

Draft Oral Tablet 203094 9/2015

 Cysteamine bitartrate (PDF - 30KB)

Draft  Oral Capsule, Delayed Release 203389 9/2015

 Dapagliflozin propanediol; Metformin HCl (PDF - 42KB) 

Draft Oral Tablet, Extended Release 205649 9/2015

 Desvenlafaxine fumarate (PDF - 46KB) 

Draft Oral Tablet, Extended Release 205583 9/2015

Eslicarbazepine acetate (PDF - 39KB)

Draft Oral Tablet 022416 9/2015

 Esomeprazole magnesium (PDF - 63KB) 

Draft Oral Capsule, Delayed Release 204655 9/2015

 Ferric citrate (PDF - 29KB)

Draft Oral Tablet 205874 9/2015

 Fluticasone propionate (PDF - 197KB)

Draft Nasal Spray, metered 020121 9/2015

 Fluticasone propionate  (PDF - 39KB)

Draft  Nasal Spray, metered 205434  9/2015

 Formoterol fumarate (PDF - 99KB)

Draft Inhalation Powder 020831 9/2015

 Idelalisib (PDF - 42KB)

Draft Oral Tablet 205858 9/2015

 Ledipasvir; Sofosbuvir (PDF - 52KB)

Draft Oral Tablet 205834 9/2015

 Levocarnitine (PDF - 40KB)

Draft Oral Tablet 018948 9/2015

 Loperamide HCl; simethicone (PDF - 39KB)

Draft Oral Tablet 021140 9/2015

 Mometasone furoate monohydrate (PDF - 113KB)

Draft Nasal Spray, Metered 020762 9/2015

 Netupitant; Palonosetron HCl (PDF - 52KB) 

Draft Oral Capsule 205718 9/2015

 Nintedanib esylate (PDF - 40KB)

Draft Oral Capsule 205832 9/2015

 Nortriptyline HCl (PDF - 38KB)

Draft Oral Capsule 018013 9/2015

 I. Ombitasvir; paritaprevir; ritonavir, and II. Dasabuvir sodium (PDF - KB)

Draft Oral Tablets, Co-packaged 206619 9/2015

 Pirfenidone  (PDF - 23KB) 

Draft Oral Capsule 022535 9/2015

 Pomalidomide (PDF - 24KB)

Draft Oral Capsule 204026 9/2015

 Ponatinib HCl (PDF - 42KB)

Draft Oral Tablet 203469 9/2015

 the word new in a red boxProgesterone (PDF - 106KB)

Draft Vaginal Gel 020701 10/2015

  Rivaroxaban (PDF - 52KB)

Draft Oral Tablet 22406 9/2015

 Ruxolitinib phosphate (PDF - 39KB)

Draft Oral Tablet 202192 9/2015

 Suvorexant  (PDF - 39KB)

Draft Oral Tablet 204569 9/2015

 Tasimelteon  (PDF - 38KB) 

Draft Oral Capsule 205677 9/2015

 Tedizolid phosphate (PDF - 23KB)

Draft Oral Tablet 205435 9/2015

 Tramadol HCl (PDF - 43KB)

Draft Oral Capsule, Extended Release 22370 9/2015

 Trimipramine maleate (PDF - 39KB)

Draft Oral Capsule 016792 9/2015


Newly Revised Bioequivalence Recommendations since June 30, 2015

Active Ingredient
(link to Specific Guidance)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date Recommended
Acitretin (PDF - 131 KB) Revised Draft Oral Capsule 19821 9/2015
Amantadine HCl (PDF - 32KB) Revised Draft Oral Capsule 71293 9/2015
Benzonatate (PDF - 39KB)Revised Draft Oral Capsule





Carbamazepine (PDF - 35KB)Revised Draft Oral Tablet 16608 9/2015
Colesevelam HCl (PDF - 18KB)
Draft Oral Tablet 21176 9/2015
Cyclophosphamide (PDF -KB)Revised Draft  Oral Tablet 040032 9/2015
 Dabigatran Etexilate Mesylate (PDF - 42KB) Revised  Draft  Oral Capsule 22512  9/2015
Dasatinib (PDF - 41KB) Revised Draft Oral Tablet 21986 9/2015
Desvenlafaxine Succinate (PDF-19KB)Revised Draft Oral Tablet, Extended Release 21992 9/2015
Esomeprazole Magnesium (PDF - 18KB) Revised Draft Oral Powder, Delayed Release




Estradiol (PDF - 157KB) Revised

Draft Transdermal Film, Extended Release 203752 9/2015
Ethinyl Estradiol; Norethindrone (PDF - 30KB) Revised Draft Oral Tablet



Gabapentin (PDF - 14KB) Revised Draft  Oral Tablet 22544 9/2015

Isotretinoin (PDF - 45KB) Revised

Draft  Oral Capsule 021951 9/2015
Minocycline HCl (PDF - 18KB) Revised Draft Oral Tablet, Extended Release 50808 9/2015
Naltrexone (PDF - 17KB) Revised Draft Intramuscular Suspension, Extended Release 21897 9/2015
Sevelamer Carbonate (PDF - 43KB)
Draft Oral Tablet 22127 9/2015
Sirolimus (PDF - 16KB)
Draft Oral Tablet 21110 9/2015



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