Details for New Drug Application (NDA): 077396
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NDA 077396 describes LORAZEPAM, which is a drug marketed by Amneal Pharms, Chartwell Molecular, Hikma, Lupin Ltd, Pharm Assoc, Bedford, Epic Pharma Llc, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Ph Health, Pharmobedient, Rising, Watson Labs, Roxane, Am Therap, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Halsey, Leading, Mutual Pharm, Oxford Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Tp Anda Holdings, Usl Pharma, Warner Chilcott, and Bedford Labs, and is included in sixty-six NDAs. It is available from thirty-four suppliers. Additional details are available on the LORAZEPAM profile page.
The generic ingredient in LORAZEPAM is lorazepam. There are eleven drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
The generic ingredient in LORAZEPAM is lorazepam. There are eleven drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
Summary for 077396
| Tradename: | LORAZEPAM |
| Applicant: | Ani Pharms |
| Ingredient: | lorazepam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077396
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LORAZEPAM | lorazepam | TABLET;ORAL | 077396 | ANDA | ANI Pharmaceuticals, Inc. | 62559-195 | 62559-195-01 | 100 TABLET in 1 BOTTLE (62559-195-01) |
| LORAZEPAM | lorazepam | TABLET;ORAL | 077396 | ANDA | ANI Pharmaceuticals, Inc. | 62559-195 | 62559-195-05 | 500 TABLET in 1 BOTTLE (62559-195-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Dec 13, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Dec 13, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Dec 13, 2006 | TE: | AB | RLD: | No | ||||
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