Details for New Drug Application (NDA): 022325
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NDA 022325 describes NEXTERONE, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the NEXTERONE profile page.
The generic ingredient in NEXTERONE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
The generic ingredient in NEXTERONE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 022325
| Tradename: | NEXTERONE |
| Applicant: | Baxter Hlthcare |
| Ingredient: | amiodarone hydrochloride |
| Patents: | 1 |
Suppliers and Packaging for NDA: 022325
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325 | NDA | Baxter Healthcare Corporation | 43066-150 | 43066-150-10 | 100 mL in 1 BAG (43066-150-10) |
| NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325 | NDA | Baxter Healthcare Corporation | 43066-360 | 43066-360-20 | 200 mL in 1 BAG (43066-360-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 24, 2008 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 150MG/100ML (1.5MG/ML) | ||||
| Approval Date: | Nov 16, 2010 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 360MG/200ML (1.8MG/ML) | ||||
| Approval Date: | Nov 16, 2010 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022325
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-001 | Dec 24, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-002 | Nov 16, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-003 | Nov 16, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-001 | Dec 24, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare | NEXTERONE | amiodarone hydrochloride | INJECTABLE;INJECTION | 022325-001 | Dec 24, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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