Details for New Drug Application (NDA): 071457
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NDA 071457 describes TEMAZEPAM, which is a drug marketed by Actavis Elizabeth, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Usa, Chartwell Rx, Duramed Pharms Barr, Novel Labs Inc, Prinston Inc, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in twenty-one NDAs. It is available from twenty-five suppliers. Additional details are available on the TEMAZEPAM profile page.
The generic ingredient in TEMAZEPAM is temazepam. There are seven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the temazepam profile page.
The generic ingredient in TEMAZEPAM is temazepam. There are seven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the temazepam profile page.
Summary for 071457
| Tradename: | TEMAZEPAM |
| Applicant: | Novel Labs Inc |
| Ingredient: | temazepam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 071457
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TEMAZEPAM | temazepam | CAPSULE;ORAL | 071457 | ANDA | Major Pharmaceuticals | 0904-6436 | 0904-6436-04 | 30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK |
| TEMAZEPAM | temazepam | CAPSULE;ORAL | 071457 | ANDA | Quality Care Products LLC | 35356-663 | 35356-663-15 | 15 CAPSULE in 1 BOTTLE (35356-663-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
| Approval Date: | Apr 21, 1987 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Jun 22, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 22.5MG | ||||
| Approval Date: | Jun 22, 2012 | TE: | AB | RLD: | No | ||||
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