Details for New Drug Application (NDA): 075135
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NDA 075135 describes PACERONE, which is a drug marketed by Upsher Smith Labs and is included in one NDA. It is available from three suppliers. Additional details are available on the PACERONE profile page.
The generic ingredient in PACERONE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
The generic ingredient in PACERONE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 075135
| Tradename: | PACERONE |
| Applicant: | Upsher Smith Labs |
| Ingredient: | amiodarone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075135
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PACERONE | amiodarone hydrochloride | TABLET;ORAL | 075135 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0144 | 0245-0144-01 | 100 BLISTER PACK in 1 CARTON (0245-0144-01) / 1 TABLET in 1 BLISTER PACK (0245-0144-89) |
| PACERONE | amiodarone hydrochloride | TABLET;ORAL | 075135 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0144 | 0245-0144-11 | 100 TABLET in 1 BOTTLE (0245-0144-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Apr 30, 1998 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 12, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Jul 2, 2020 | TE: | AB | RLD: | No | ||||
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