Details for New Drug Application (NDA): 202383
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The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
Summary for 202383
Tradename: | LAMOTRIGINE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | lamotrigine |
Patents: | 0 |
Pharmacology for NDA: 202383
Mechanism of Action | Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 202383
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 202383 | ANDA | NorthStar Rx LLC | 16714-623 | 16714-623-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-623-01) |
LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 202383 | ANDA | NorthStar Rx LLC | 16714-624 | 16714-624-01 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-624-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
Approval Date: | Jun 19, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG | ||||
Approval Date: | Jun 19, 2013 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Jun 19, 2013 | TE: | AB | RLD: | No |
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