Details for New Drug Application (NDA): 076697
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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 076697
Tradename: | CARBAMAZEPINE |
Applicant: | Nostrum Labs Inc |
Ingredient: | carbamazepine |
Patents: | 0 |
Suppliers and Packaging for NDA: 076697
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARBAMAZEPINE | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 076697 | ANDA | Nostrum Laboratories, Inc. | 29033-004 | 29033-004-12 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29033-004-12) |
CARBAMAZEPINE | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 076697 | ANDA | Nostrum Laboratories, Inc. | 29033-019 | 29033-019-12 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29033-019-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | May 20, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
Approval Date: | May 20, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
Approval Date: | May 20, 2011 | TE: | AB | RLD: | No |
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