Details for New Drug Application (NDA): 076868
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NDA 076868 describes LOXAPINE SUCCINATE, which is a drug marketed by Elite Labs Inc, Lannett Co Inc, Rising, and Watson Labs, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the LOXAPINE SUCCINATE profile page.
The generic ingredient in LOXAPINE SUCCINATE is loxapine succinate. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the loxapine succinate profile page.
The generic ingredient in LOXAPINE SUCCINATE is loxapine succinate. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the loxapine succinate profile page.
Summary for 076868
| Tradename: | LOXAPINE SUCCINATE |
| Applicant: | Elite Labs Inc |
| Ingredient: | loxapine succinate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076868
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOXAPINE SUCCINATE | loxapine succinate | CAPSULE;ORAL | 076868 | ANDA | Elite Laboratories, Inc. | 64850-890 | 64850-890-01 | 100 CAPSULE in 1 BOTTLE (64850-890-01) |
| LOXAPINE SUCCINATE | loxapine succinate | CAPSULE;ORAL | 076868 | ANDA | Elite Laboratories, Inc. | 64850-891 | 64850-891-01 | 100 CAPSULE in 1 BOTTLE (64850-891-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Aug 4, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Aug 4, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Aug 4, 2005 | TE: | AB | RLD: | No | ||||
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