Details for New Drug Application (NDA): 078898
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NDA 078898 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 078898
| Tradename: | GALANTAMINE HYDROBROMIDE |
| Applicant: | Zydus Pharms Usa Inc |
| Ingredient: | galantamine hydrobromide |
| Patents: | 0 |
Pharmacology for NDA: 078898
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 078898
Suppliers and Packaging for NDA: 078898
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | TABLET;ORAL | 078898 | ANDA | Zydus Lifesciences Limited | 65841-755 | 65841-755-01 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-755-01) |
| GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | TABLET;ORAL | 078898 | ANDA | Zydus Lifesciences Limited | 65841-755 | 65841-755-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-755-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Feb 17, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 8MG BASE | ||||
| Approval Date: | Feb 17, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 12MG BASE | ||||
| Approval Date: | Feb 17, 2011 | TE: | AB | RLD: | No | ||||
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