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Details for New Drug Application (NDA): 204895
» See Plans and Pricing
NDA 204895 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Barr, Impax Labs, Mylan, Sun Pharm, Watson Labs, Hikma, Apotex Inc, 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 204895
| Tradename: | GALANTAMINE HYDROBROMIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | galantamine hydrobromide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204895
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204895
Suppliers and Packaging for NDA: 204895
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 204895 | ANDA | Aurobindo Pharma Limited | 65862-744 | 65862-744-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-01) |
| GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 204895 | ANDA | Aurobindo Pharma Limited | 65862-744 | 65862-744-05 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 8MG BASE | ||||
| Approval Date: | Aug 5, 2016 | 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: | Aug 5, 2016 | 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: | Aug 5, 2016 | TE: | AB | RLD: | No | ||||
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