GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26775
Submission : 2012-12-03
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Co-Processed Excipients
Excipient Details : AHMC 0600 is a co-processed aluminum hydroxide and magnesium carbonate powder used in immediate-relief antacid tablet formulation.
Pharmacopoeia Ref : NA
Technical Specs : Apparent Density: 0.30-0.40 (g/mL)
Ingredient(s) : Aluminum Hydroxide Excipient
Application : Co-Processed Excipients
Excipient Details : AHMC 0611 is a co-processed aluminum hydroxide & magnesium carbonate micronized powder used in immediate-relief antacid tablets & liquid suspensions.
Pharmacopoeia Ref : NA
Technical Specs : Tapped NMT: 0.2
Ingredient(s) : Aluminum Hydroxide Excipient
Application : Thickeners and Stabilizers
Excipient Details : SPI® VAC Gels are based on highly engineered pseudo-boehmite and are used as vaccine adjuvants.