Details for New Drug Application (NDA): 079028
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NDA 079028 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma, Barr, Impax Labs, Mylan, Sun Pharm, Watson Labs, Hikma, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Heritage Pharma, Sandoz, Yabao Pharm, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from twelve 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 079028
| Tradename: | GALANTAMINE HYDROBROMIDE |
| Applicant: | Watson Labs |
| Ingredient: | galantamine hydrobromide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 079028
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 079028
Suppliers and Packaging for NDA: 079028
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 079028 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-984 | 43353-984-05 | 4200 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-984-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 8MG BASE | ||||
| Approval Date: | Dec 15, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 16MG BASE | ||||
| Approval Date: | Dec 15, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 24MG BASE | ||||
| Approval Date: | Dec 15, 2008 | TE: | AB | RLD: | No | ||||
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