Details for New Drug Application (NDA): 077604
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The generic ingredient in GALANTAMINE HYDROBROMIDE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 077604
Tradename: | GALANTAMINE HYDROBROMIDE |
Applicant: | Yabao Pharm |
Ingredient: | galantamine hydrobromide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077604
Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 077604
Suppliers and Packaging for NDA: 077604
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | TABLET;ORAL | 077604 | ANDA | Major Pharmaceuticals | 0904-7104 | 0904-7104-04 | 30 BLISTER PACK in 1 CARTON (0904-7104-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | TABLET;ORAL | 077604 | ANDA | TWi Pharmaceuticals USA, Inc. | 24979-722 | 24979-722-04 | 60 TABLET, FILM COATED in 1 BOTTLE (24979-722-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Feb 6, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 8MG BASE | ||||
Approval Date: | Feb 6, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 12MG BASE | ||||
Approval Date: | Feb 6, 2009 | TE: | AB | RLD: | No |
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