Drugs

Product-Specific Guidances for Generic Drug Development: Active Ingredients starting with 'D'

Product-Specific Guidances for Specific Products Arranged by Active Ingredient
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

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date
Recommended
Dabigatran Etexilate Mesylate (PDF - 42KB)  Draft OralCapsule22512 7/2017

Dabrafenib mesylate (PDF - 24KB)  

DraftOralCapsule2028066/2015

Daclatasvir dihydrochloride (PDF - 39KB)

DraftOralTablet2068434/2016
Dalfampridine (PDF - 45KB) Draft OralTablet, Extended Release22250 3/2012
Dalteparin Sodium (PDF - 26KB)Draft Subcutaneous Injection202879/2012
Danazol (PDF-49KB)FinalOralCapsule745825/2008
Dantrolene Sodium (PDF-41KB)FinalOralCapsule0174435/2007

Dapagliflozin Propanediol (PDF - 23KB) 

DraftOralTablet2022936/2015

Dapagliflozin propanediol; Metformin HCl (PDF - 42KB) 

DraftOralTablet, Extended Release2056499/2015
Dapsone (PDF - 33KB)FinalOralTablet

86841 

86842

8/2017
Dapsone (PDF - 103KB) RevisedDraft TopicalGel, 5%2179412/2014
Darifenacin HBr (PDF-46KB)FinalOralTablet, Extended Release215135/2008
Darunavir Ethanolate (PDF-49KB) RevisedDraftOralTablet219764/2013
Darunavir Ethanolate (PDF - 20KB)DraftOralSuspension20289512/2014
Dasatinib (PDF - 41KB) DraftOralTablet219869/2015

Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir (PDF - 42KB)

DraftOralTablets, Extended Release2086247/2017
Daunorubicin citrate (PDF - 83KB)DraftIntravenousInjection, Liposome507047/2014

Deferasirox  (PDF - 39KB)

Draft OralTablet2069104/2016
Deferasirox (PDF-43KB)FinalOralTablet, For Suspension218825/2008

Deferiprone (PDF - 40KB) Revised

DraftOralTablet0218255/2017
Delavirdine Mesylate (PDF-18KB)DraftOralTablet2070511/2007
Demeclocycline HCl (PDF-15KB)DraftOralTablet5026110/2008
Desipramine HCl (PDF -22KB)FinalOralTablet

14399

8/2017
Desloratadine (PDF-53KB)FinalOralTablet, Orally Disintegrating213125/2008
Desloratadine (PDF-44KB)FinalOralTablet211655/2008
Desmopressin Acetate (PDF-33KB)FinalOralTablet199558/2017
Desogestrel; Ethinyl Estradiol (PDF-16KB)  revisedDraftOralTablet203013/2010
Desogestrel; Ethinyl Estradiol (PDF-22KB)DraftOralTablet210903/2009
Desogestrel; Ethinyl Estradiol (PDF-19KB)
Revised
DraftOralTablet207137/2009

Desonide (PDF - 35KB)

DraftTopicalOintment

017426

10/2016

Desonide (PDF -43KB) 

Draft TopicalCream0170101/2016

Desonide (PDF - 38KB)

DraftTopicalLotion0723541/2016

Desoximetasone  (PDF - 23KB)

Draft TopicalSpray2041413/2015
Desoximetasone (PDF - 25KB)DraftTopicalCream

018309

017856

4/2014

Desoximetasone (PDF - 42KB)

DraftTopicalOintment18594

 

4/2014

Desvenlafaxine (PDF - 25KB)

DraftOralTablet, Extended Release

204150

4/2013

Desvenlafaxine fumarate (PDF - 46KB) 

DraftOralTablet, Extended Release2055839/2015
Desvenlafaxine Succinate (PDF-19KB)RevisedDraftOralTablet, Extended Release219929/2015
Dexamethasone (PDF - 38KB)DraftOralTablet

011664

6/2011
Dexamethasone; Tobramycin (PDF - 64KB) Draft OphthalmicOintment50616 6/2016
Dexamethasone; Tobramycin (PDF-49KB)DraftOphthalmicSuspension508186/2016
Dexamethasone;Tobramycin (PDF - 35 KB) DraftOphthalmicSuspension505926/2016

Dexbrompheniramine maleate; pseudoephedrine sulfate (PDF - 42KB)

DraftOralCapsule0134836/2015

Dexlansoprazole (PDF - 51B)

DraftOralTablet, Delayed release orally disintegrating20805610/2016
Dexlansoprazole (PDF - 47KB) RevisedDraftOralCapsule, Delayed Release22287  10/2012
Dexmethylphenidate (PDF-18KB)DraftOralTablet212782/2008
Dexmethylphenidate HCl (PDF - 130KB)  Draft OralCapsule, Extended Release218023/2015
Dextroamphetamine Sulfate (PDF-18KB) DraftOralCapsule, Extended Release170783/2015

Dextroamphetamine sulfate (PDF -38KB)

DraftOralTablet0403617/2017
Dextromethorphan Hydrobromide; Guaifenesin (PDF-18KB)DraftOralTablet, Extended Release2162012/2008
Dextromethorphan Hydrobromide; Quinidine Sulfate (PDF - 39KB)Revised Draft OralCapsule21879 4/2013
Dextromethorphan Polistirex (PDF-55KB)FinalOralSuspension, Extended Release186585/2008
Diazepam (PDF - 32KB)DraftRectalGel206487/2010
Diazoxide (PDF - 22KB)DraftOralSuspension174534/2014

Diclofenac  (PDF - 23KB)

DraftOralCapsule2045923/2015
Diclofenac Epolamine (PDF - 595KB)  Revised DraftTopicalPatch21234 10/2016
Diclofenac Potassium (PDF - 33KB)DraftOralCapsule222024/2011

Diclofenac sodium (PDF - 60KB) 

DraftTopicalSolution2046237/2017
Diclofenac Sodium (PDF - 33KB)DraftTopicalSolution209476/2011
Diclofenac Sodium (PDF - 197KB)DraftTopicalGel221222/2011
Diclofenac Sodium (PDF - 172KB)DraftTopicalGel210051/2011
Diclofenac Sodium (PDF-18KB)DraftOralTablet, Delayed Release

19201

10/2009
Diclofenac Sodium (PDF-18KB)DraftOralTablet, Extended Release2025410/2009
Diclofenac Sodium (PDF-19KB) RevisedDraftOphthalmicSolution/Drops200378/2017
Diclofenac sodium; misoprostol (PDF-18KB)
revised
DraftOralTablet, Delayed Release2060712/2009
Dicloxacillin Sodium (PDF-41KB)FinalOralCapsule614545/2008
Didanosine (PDF-41KB)  RevisedDraftOralTablet, For Suspension772756/2013
Didanosine (PDF-44KB)FinalOralCapsule, Delayed Release Pellets211835/2008
Dienogest;Estradiol Valerate (PDF - 38KB)DraftOralTablet2225212/2010
Diethylpropion HCl (PDF - 20 KB)DraftOralTablet, Extended Release1254612/2009
Diflorasone Diacetate (PDF - 22KB)DraftTopicalOintment0192607/2014

Diflorasone diacetate  (PDF - 38KB)

DraftTopicalCream0755081/2016

Diflorasone diacetate (PDF - 38KB)

DraftTopicalCream0762631/2016
Diflunisal (PDF-15KB) FinalOralTablet184458/2017

Difluprednate (PDF - 57KB) Revised

DraftOphthalmicEmulsion0222122/2017
Digoxin (PDF-53KB) RevisedDraftOralTablet204058/2017
Diltiazem HCl (PDF-19KB)DraftOralCapsule, Extended Release200622/2008
Diltiazem HCl (PDF-20KB)DraftOralCapsule, Extended Release200922/2008
Diltiazem HCl (PDF-21KB)DraftOralCapsule, Extended Release204012/2008
Diltiazem HCl (PDF-19KB)DraftOralTablet, Extended Release213922/2008
Dimethyl Fumarate (PDF - 24KB)DraftOralCapsule, Delayed Release2040637/2014
Dinoprostone (PDF - 162KB) Draft VaginalSuppository17810 6/2012
Dinoprostone (PDF - 155KB) DraftVaginalInsert, Extended Release2041111/2011
Dinoprostone (PDF - 159KB) DraftEndocervicalGel196179/2011
Diphenhydramine Citrate;Ibuprofen (PDF-26KB)DraftOralTablet213942/2010
Diphenhydramine HCl (PDF -23KB)FinalOralCapsule.0807388/2017
Diphenhydramine HCl and Ibuprofen (PDF - 33KB) Draft OralCapsule213936/2012
 

Diphenhydramine HCl; naproxen sodium (PDF - 23KB) 

DraftOralTablet2053523/2015
Dipyridamole (PDF-41KB)FinalOralTablet128368/2017
Disopyramide Phosphate (PDF-20KB)DraftOralCapsule174478/2008
Disopyramide Phosphate (PDF-16KB)DraftOralCapsule, Extended Release1865510/2008
Disulfiram (PDF - 26 KB)FinalOralTablet

007883

8/2017
Divalproex Sodium (PDF-19KB) RevisedDraftOralTablet, Delayed Release1872312/2016
Divalproex Sodium (PDF-19KB) RevisedDraftOralCapsule, Delayed Release Pellets1968012/2016
Divalproex Sodium (PDF-57KB) RevisedDraftOralTablet, Extended Release2116812/2016
Dofetilide (PDF-43KB)FinalOralCapsule209315/2008
Dolasetron Mesylate (PDF - 36KB)DraftOralTablet206235/2010

Dolutegravir sodium (PDF - 39KB) Revised

Draft OralTablet2047905/2017
Donepezil HCl (PDF - 49KB)FinalOralTablet225688/2017
Donepezil HCl (PDF-22KB)
Revised
DraftOralTablet, Orally Disintegrating217204/2010
Donepezil HCl (PDF-22KB)
Revised
DraftOralTablet206904/2010

Donepezil HCl; Memantine HCl (PDF - 48KB)

DraftOralCapsule, Extended Release2064396/2015

Dorzolamide HCl (PDF - 84KB)

DraftOphthalmicSolution/drops204087/2017
Doxazosin Mesylate (PDF - 35KB)FinalOralTablet196688/2017
Doxazosin Mesylate (PDF-47KB)FinalOralTablet, Extended Release212695/2008

Doxepin HCl (PDF - 40KB)

FinalOralCapsule167988/2017
Doxepin HCl (PDF - 34KB)DraftOralTablet220369/2010
Doxepin HCl (PDF - 35KB) RevisedDraftOralCapsule

016798

3/2015
Doxercalciferol (PDF-30KB)
FinalOralCapsule208628/2017
Doxorubicin HCl (PDF-66KB)RevisedDraftInjectionInjectable, Liposomal507184/2017
Doxycycline (PDF - 42KB)DraftOralCapsule0506417/2014
Doxycycline (PDF - 42KB)DraftOralCapsule0650557/2014
Doxycycline (PDF-18KB)DraftOralCapsule, Delayed Release508052/2008
Doxycycline (PDF-18KB)DraftOralTablet0650701/2008
Doxycycline (PDF-17KB)DraftOralSuspension500068/2008

Doxycycline hyclate (PDF - 38KB)

Draft OralCapsule20825312/2016

Doxycycline hyclate  (PDF - 38KB)

DraftOralTablet0505334/2016

Doxycycline Hyclate (PDF - 42KB)

DraftOralTablet2059316/2015
Doxycycline Hyclate (PDF-16KB)DraftOralCapsule500077/2008
Doxycycline Hyclate (PDF-19KB) RevisedDraftOralTablet, Delayed Release507956/2014
Doxylamine Succinate; Pyridoxine HCl (PDF - 27KB)DraftOralTablet, Delayed Release218767/2014
Dronabinol (PDF-25KB) RevisedDraftOralCapsule186512/2014

Dronedarone HCl (PDF - 62KB) Revised

DraftOralTablet224257/2014
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium (PDF - 52KB)Draft Draft OralTablet

22532

22574

 3/2012
Drospirenone; Estradiol (PDF-43KB) RevisedDraftOralTablet213551/2016
Drospirenone; Ethinyl Estradiol (PDF-21KB)RevisedDraftOralTablet2167611/2013
Drospirenone; Ethinyl Estradiol (PDF-21KB)DraftOralTablet210983/2009

Droxidopa (PDF -39KB)

DraftOralCapsule2032026/2015
Duloxetine HCl (PDF-57KB) RevisedDraftOralCapsule, Delayed Release Pellets214277/2014
Dutasteride (PDF-55KB)FinalOralCapsule213195/2008
Dutasteride;Tamsulosin HCl (PDF -62KB) RevisedDraft OralCapsule0224602/2014

 

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