Details for New Drug Application (NDA): 077242
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The generic ingredient in GABAPENTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 077242
Tradename: | GABAPENTIN |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | gabapentin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077242
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 077242
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GABAPENTIN | gabapentin | CAPSULE;ORAL | 077242 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-137 | 62756-137-01 | 50 CAPSULE in 1 BOX, UNIT-DOSE (62756-137-01) |
GABAPENTIN | gabapentin | CAPSULE;ORAL | 077242 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-137 | 62756-137-02 | 100 CAPSULE in 1 BOTTLE (62756-137-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 24, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Aug 24, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 400MG | ||||
Approval Date: | Aug 24, 2006 | TE: | AB | RLD: | No |
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