Drugs

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

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
Zafirlukast (PDF - 17KB)DraftOralTablet205472/2008
Zaleplon (PDF - 43KB)FinalOralCapsule208595/2008
Zalcitabine (PDF - 18KB)DraftOralTablet201992/2008
Zidovudine (PDF - 44KB)FinalOralCapsule196555/2008
Zidovudine (PDF - 41KB)FinalOralTablet900925/2008
Zileuton (PDF - 17KB)DraftOralTablet, Extended Release220527/2008
Zileuton (PDF - 18KB)DraftOralTablet204711/2008
Ziprasidone HC (PDF - 18KB)lDraftOralSuspension214837/2008
Ziprasidone HCl (PDF - 44KB)FinalOralCapsule208255/2008
Zolmitriptan (PDF - 17KB)DraftOralTablet207682/2010

Zolmitriptan  (PDF - 26KB)

DraftNasalSpray0214507/2014
Zolmitriptan (PDF - 16KB)
Revised
DraftOralTablet, Orally Disintegrating212319/2008
Zolpidem (PDF - 33KB)DraftOralTablet, Sublingual219979/2010
Zolpidem (PDF - 49KB)FinalOralTablet, Extended Release2177410/2011
Zolpidem Tartrate (PDF - 25KB)DraftOralSpray0221964/2013
 Zolpidem Tartrate (PDF - 40KB) Draft OralTablet, Sublingual22328 6/2012
Zolpidem Tartrate (PDF - 33KB)DraftOralTablet199085/2007
Zonisamide (PDF - 18KB)DraftOralCapsule207891/2008

 

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