Details for New Drug Application (NDA): 203572
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NDA 203572 describes LORAZEPAM, which is a drug marketed by Amneal Pharms, Chartwell Molecular, Hikma, Lupin Ltd, Pharm Assoc, Bedford, Dr Reddys, Endo Operations, Epic Pharma Llc, Hospira, Intl Medication Sys, Rising, Watson Labs, Roxane, Am Therap, Anda Repository, Ani Pharms, Aurolife Pharma Llc, Chartwell Rx, Halsey, Leading, Mutual Pharm, Oxford Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Warner Chilcott, and Bedford Labs, and is included in sixty-four NDAs. It is available from thirty-three 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
Summary for 203572
| Tradename: | LORAZEPAM |
| Applicant: | Aurolife Pharma Llc |
| Ingredient: | lorazepam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203572
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LORAZEPAM | lorazepam | TABLET;ORAL | 203572 | ANDA | Aurolife Pharma LLC | 13107-083 | 13107-083-01 | 100 TABLET in 1 BOTTLE (13107-083-01) |
| LORAZEPAM | lorazepam | TABLET;ORAL | 203572 | ANDA | Aurolife Pharma LLC | 13107-083 | 13107-083-05 | 500 TABLET in 1 BOTTLE (13107-083-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Dec 22, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Dec 22, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Dec 22, 2017 | TE: | AB | RLD: | No | ||||
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