Details for New Drug Application (NDA): 078986
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The generic ingredient in CARBAMAZEPINE is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 078986
Tradename: | CARBAMAZEPINE |
Applicant: | Apotex Inc |
Ingredient: | carbamazepine |
Patents: | 0 |
Suppliers and Packaging for NDA: 078986
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARBAMAZEPINE | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 078986 | ANDA | Major Pharmaceuticals | 0904-6885 | 0904-6885-04 | 30 BLISTER PACK in 1 CARTON (0904-6885-04) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK |
CARBAMAZEPINE | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 078986 | ANDA | AvPAK | 50268-170 | 50268-170-13 | 30 BLISTER PACK in 1 BOX (50268-170-13) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-170-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 25, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
Approval Date: | Nov 25, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
Approval Date: | Nov 25, 2011 | TE: | AB | RLD: | No |
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