Details for New Drug Application (NDA): 078185
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The generic ingredient in GALANTAMINE HYDROBROMIDE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 078185
Tradename: | GALANTAMINE HYDROBROMIDE |
Applicant: | Hikma |
Ingredient: | galantamine hydrobromide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078185
Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 078185
Suppliers and Packaging for NDA: 078185
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | SOLUTION;ORAL | 078185 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0137 | 0054-0137-49 | 100 mL in 1 BOTTLE (0054-0137-49) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 4MG/ML | ||||
Approval Date: | Jan 30, 2009 | TE: | RLD: | No |
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