GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39247
Submission : 2023-12-06
Status : Active
Type : II
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : API Stability Enhancers
Excipient Details : Polysorbate 80 in dry powder form, a solubilizing agent acts as a surfactant and increases the solubility of various oral dosage forms.
Pharmacopoeia Ref : USP-NF, EP, JP & having US DMF
Technical Specs : Solubilizer in powder form, used in directly compressible dosage ...
Ingredient(s) : Magnesium aluminium silicate Excipient
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