Details for New Drug Application (NDA): 204895
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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 204895
Tradename: | GALANTAMINE HYDROBROMIDE |
Applicant: | Aurobindo Pharma |
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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