Individual Product Bioequivalence Recommendations

• Draft Guidance for Industry: Bioequivalence Recommendations for Specific Products (PDF - 45 KB) (Issued May 2007)

 

Dissolutions Methods Database

 

Individual Product Bioequivalence Recommendations Arranged by Active Ingredient [Total count 416]
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

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Newly Added Recommendations - May 2009 (21) updated 7/2/2009

 

 

Active Ingredient (link to Specific Guidance)	Type	Route of Administration	Dosage Form	RLD Application Number (link to Orange Book)	Date Recommended
Acarbose	Draft	Oral	Tablet	20482	7/2009
Amlodipine Besylate; Atorvastatin Calcium	Draft	Oral	Tablet	21540	5/2009
Ciprofloxacin	Draft	Oral	Suspension	20780	5/2009
Doxycycline Hyclate	Draft	Oral	Tablet, Delayed Release	50795	5/2009
Eletriptan Hydrobromide	Draft	Oral	Tablet	21016	5/2009
Ethinyl Estradiol; Norelgestromin	Draft	Transdermal	Film, Extend Release	21180	5/2009
Ethinyl Estradiol; Norethindrone	Draft	Oral	Tablet	18985 17735 17919	5/2009
Fentanyl	Draft	Transdermal	Film, Extend Release	19813	5/2009
Glimepiride; Pioglitazone HCl	Draft	Oral	Tablet	21925	5/2009
Lansoprazole	Draft	Oral	Capsule, Delayed Release	20406	5/2009
Methylprenisolone Acetate	Draft	Injection	Suspension	11757	5/2009
Metoclopramide HCl	Draft	Oral	Tablet	17854	5/2009
Nadolol	Draft	Oral	Tablet	18063	5/2009
Nisoldipine	Draft	Oral	Tablet, Extended Release	20356	5/2009
Phentermine HCl	Draft	Oral	Capsule	88023 87190	5/2009
Phentermine HCl	Draft	Oral	Tablet	85128 88605	5/2009
Phytonadione	Draft	Injectable	Injection	87954 87955	5/2009
Pregabalin	Draft	Oral	Capsule	21446	5/2009
Propafenone HCl	Draft	Oral	Tablet	19151	5/2009
Sodium Phenylbutyrate	Draft	Oral	Powder	20573	5/2009
Sodium Phenylbutyrate	Draft	Oral	Tablet	20572	5/2009
Tamoxifen Citrate	Draft	Oral	Tablet	74858 75797	5/2009