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U.S. Department of Health and Human Services

Drugs

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Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'Z'

 

Bioequivalence Recommendations 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)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date
Recommended
Zafirlukast (PDF - 17KB) Draft Oral Tablet 20547 2/2008
Zaleplon (PDF - 43KB) Final Oral Capsule 20859 5/2008
Zalcitabine (PDF - 18KB) Draft Oral Tablet 20199 2/2008
Zidovudine (PDF - 44KB) Final Oral Capsule 19655 5/2008
Zidovudine (PDF - 41KB) Final Oral Tablet 90092 5/2008
Zileuton (PDF - 17KB) Draft Oral Tablet, Extended Release 22052 7/2008
Zileuton (PDF - 18KB) Draft Oral Tablet 20471 1/2008
Ziprasidone HC (PDF - 18KB)l Draft Oral Suspension 21483 7/2008
Ziprasidone HCl (PDF - 44KB) Final Oral Capsule 20825 5/2008
Zolmitriptan (PDF - 17KB) Draft Oral Tablet 20768 2/2010

Zolmitriptan  (PDF - 26KB)

Draft Nasal Spray 021450 7/2014
Zolmitriptan (PDF - 16KB)
Revised
Draft Oral Tablet, Orally Disintegrating 21231 9/2008
Zolpidem (PDF - 33KB) Draft Oral Tablet, Sublingual 21997 9/2010
Zolpidem (PDF - 49KB) Final Oral Tablet, Extended Release 21774 10/2011
Zolpidem Tartrate (PDF - 25KB) Draft Oral Spray 022196 4/2013
 Zolpidem Tartrate (PDF - 40KB)  Draft  Oral Tablet, Sublingual 22328  6/2012
Zolpidem Tartrate (PDF - 33KB) Draft Oral Tablet 19908 5/2007
Zonisamide (PDF - 18KB) Draft Oral Capsule 20789 1/2008