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US Food and Drug Administration (FDA) - Inactive Ingredients

FDA Inactive Ingredients - Updated May 2006

What is the purpose of the Inactive Ingredients Database?

The Inactive Ingredients Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products. For new drug development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new and may require a less extensive review the next time it is included in a new drug product. For example, if a particular inactive ingredient has been approved in a certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product.
FDA Devices
FDA Inactive Ingredients
FDA Inactive Ingredients
FDA Inactive Ingredients


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Inactive Ingredient Route / Dosage Form
LACTOSE ORAL; POWDER, FOR SOLUTION
LACTOSE ORAL; SOLUTION
LACTOSE ORAL; TABLET
LACTOSE ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
LACTOSE ORAL; TABLET, COATED
LACTOSE ORAL; TABLET, CONTROLLED RELEASE
LACTOSE ORAL; TABLET, DELAYED ACTION
LACTOSE ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
LACTOSE ORAL; TABLET, FILM COATED
LACTOSE ORAL; TABLET, MULTILAYER, EXTENDED RELEASE
LACTOSE ORAL; TABLET, REPEAT ACTION
LACTOSE ORAL; TABLET, SUSTAINED ACTION
LACTOSE ORAL; TABLET, SUSTAINED ACTION, FILM COATED
LACTOSE ORAL; TABLET, SUSTAINED RELEASE, FILM COATED
LACTOSE ORAL-20; TABLET
LACTOSE ORAL-21; TABLET
LACTOSE ORAL-28; TABLET
LACTOSE RECTAL; SOLUTION
LACTOSE RECTAL; TABLET
LACTOSE SUBCUTANEOUS; POWDER, FOR INJECTION SOLUTION
LACTOSE SUBCUTANEOUS; POWDER, FOR INJECTION SOLUTION, LYOPHILIZED
LACTOSE SUBLINGUAL; TABLET
LACTOSE TRANSDERMAL; FILM, CONTROLLED RELEASE
LACTOSE TRANSDERMAL; OINTMENT
LACTOSE VAGINAL; EMULSION, CREAM
LACTOSE VAGINAL; SUPPOSITORY
LACTOSE VAGINAL; TABLET
LACTOSE MONOHYDRATE BUCCAL; TABLET
LACTOSE MONOHYDRATE IM - IV - SC; POWDER, FOR INJECTION SOLUTION, LYOPHILIZED
LACTOSE MONOHYDRATE IM - IV; POWDER
LACTOSE MONOHYDRATE IM - SC; INJECTION
LACTOSE MONOHYDRATE INTRACAVITARY; POWDER, FOR INJECTION SOLUTION, LYOPHILIZED
LACTOSE MONOHYDRATE INTRAMUSCULAR; INJECTION
LACTOSE MONOHYDRATE INTRAVENOUS; INJECTION
LACTOSE MONOHYDRATE INTRAVENOUS; POWDER, FOR INJECTION SOLUTION, LYOPHILIZED
LACTOSE MONOHYDRATE IV - SC; INJECTION
LACTOSE MONOHYDRATE IV(INFUSION); POWDER, FOR INJECTION SOLUTION
LACTOSE MONOHYDRATE IV(INFUSION); POWDER, FOR INJECTION SOLUTION, LYOPHILIZED
LACTOSE MONOHYDRATE IV(INFUSION); POWDER, FOR INJECTION SUSPENSION, LYOPHILIZED
LACTOSE MONOHYDRATE ORAL; CAPSULE
LACTOSE MONOHYDRATE ORAL; CAPSULE, COATED, SOFT GELATIN
LACTOSE MONOHYDRATE ORAL; CAPSULE, EXTENDED RELEASE
LACTOSE MONOHYDRATE ORAL; CAPSULE, HARD GELATIN
LACTOSE MONOHYDRATE ORAL; CAPSULE, SUSTAINED ACTION
LACTOSE MONOHYDRATE ORAL; CAPSULE, SUSTAINED ACTION, HARD GELATIN
LACTOSE MONOHYDRATE ORAL; DISPERSIBLE TABLET
LACTOSE MONOHYDRATE ORAL; POWDER, FOR INHALATION
LACTOSE MONOHYDRATE ORAL; POWDER, FOR SUSPENSION
LACTOSE MONOHYDRATE ORAL; TABLET
LACTOSE MONOHYDRATE ORAL; TABLET (IMMED./COMP. RELEASE), FILM COATED
LACTOSE MONOHYDRATE ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
LACTOSE MONOHYDRATE ORAL; TABLET, COATED
LACTOSE MONOHYDRATE ORAL; TABLET, CONTROLLED RELEASE
LACTOSE MONOHYDRATE ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
LACTOSE MONOHYDRATE ORAL; TABLET, ENTERIC COATED PARTICLES
LACTOSE MONOHYDRATE ORAL; TABLET, EXTENDED RELEASE
LACTOSE MONOHYDRATE ORAL; TABLET, FILM COATED
LACTOSE MONOHYDRATE ORAL; TABLET, MULTILAYER, COATED
LACTOSE MONOHYDRATE ORAL; TABLET, ORALLY DISINTEGRATING
LACTOSE MONOHYDRATE ORAL; TABLET, SUSTAINED ACTION
LACTOSE MONOHYDRATE ORAL; TABLET, SUSTAINED ACTION, COATED
LACTOSE MONOHYDRATE ORAL; TABLET, SUSTAINED ACTION, FILM COATED
LACTOSE MONOHYDRATE ORAL; TABLET, SUSTAINED ACTION, MULTILAYER, FILM COATED
LACTOSE MONOHYDRATE ORAL; TABLET, SUSTAINED RELEASE, FILM COATED
LACTOSE MONOHYDRATE ORAL-21; TABLET
LACTOSE MONOHYDRATE ORAL-21; TABLET, COATED
LACTOSE MONOHYDRATE ORAL-28; TABLET
LACTOSE MONOHYDRATE ORAL-28; TABLET, COATED
LACTOSE MONOHYDRATE RESPIRATORY (INHALATION); CAPSULE
LACTOSE MONOHYDRATE RESPIRATORY (INHALATION); POWDER, FOR INHALATION
LACTOSE MONOHYDRATE SUBLINGUAL; TABLET
LACTOSE MONOHYDRATE VAGINAL; TABLET, FILM COATED
LACTOSE, ANHYDROUS BUCCAL; TABLET
LACTOSE, ANHYDROUS IM - IV; INJECTABLE
LACTOSE, ANHYDROUS IM - IV; POWDER, FOR INJECTION SOLUTION
LACTOSE, ANHYDROUS INTRACAVITARY; POWDER, FOR INJECTION SOLUTION, LYOPHILIZED
LACTOSE, ANHYDROUS IV(INFUSION); POWDER, FOR INJECTION SOLUTION
LACTOSE, ANHYDROUS ORAL; CAPSULE
LACTOSE, ANHYDROUS ORAL; CAPSULE, COATED, SOFT GELATIN
LACTOSE, ANHYDROUS ORAL; CAPSULE, ENTERIC COATED PELLETS
LACTOSE, ANHYDROUS ORAL; CAPSULE, SUSTAINED ACTION
LACTOSE, ANHYDROUS ORAL; GRANULE
LACTOSE, ANHYDROUS ORAL; GRANULE, FOR RECONSTITUTION
LACTOSE, ANHYDROUS ORAL; POWDER, FOR INHALATION
LACTOSE, ANHYDROUS ORAL; TABLET
LACTOSE, ANHYDROUS ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE
LACTOSE, ANHYDROUS ORAL; TABLET, COATED
LACTOSE, ANHYDROUS ORAL; TABLET, CONTROLLED RELEASE
LACTOSE, ANHYDROUS ORAL; TABLET, DELAYED ACTION, ENTERIC COATED
LACTOSE, ANHYDROUS ORAL; TABLET, FILM COATED
LACTOSE, ANHYDROUS ORAL; TABLET, SUSTAINED ACTION
LACTOSE, ANHYDROUS ORAL; TABLET, SUSTAINED ACTION, COATED
LACTOSE, ANHYDROUS ORAL; TABLET, SUSTAINED ACTION, FILM COATED
LACTOSE, ANHYDROUS ORAL-21; TABLET
LACTOSE, ANHYDROUS ORAL-21; TABLET, COATED
LACTOSE, ANHYDROUS ORAL-28; TABLET
LACTOSE, ANHYDROUS ORAL-28; TABLET, COATED
LACTOSE, ANHYDROUS SUBLINGUAL; TABLET
LACTOSE, ANHYDROUS VAGINAL; TABLET
LACTOSE, HYDROUS IM - IV; INJECTION

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Last Modified: 29 April 2006
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