Details for New Drug Application (NDA): 077604
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NDA 077604 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma, Barr, Impax Labs, Norvium Bioscience, Sun Pharm, Watson Labs, Hikma, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Heritage Pharma, Mylan, Sandoz, Yabao Pharm, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from thirteen suppliers. Additional details are available on the GALANTAMINE HYDROBROMIDE profile page.
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.
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 |
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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