Details for New Drug Application (NDA): 021038
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NDA 021038 describes PRECEDEX, which is a drug marketed by Hospira and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the PRECEDEX profile page.
The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 021038
| Tradename: | PRECEDEX |
| Applicant: | Hospira |
| Ingredient: | dexmedetomidine hydrochloride |
| Patents: | 7 |
Pharmacology for NDA: 021038
| Mechanism of Action | Adrenergic alpha2-Agonists |
| Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for 021038
Suppliers and Packaging for NDA: 021038
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038 | NDA | Henry Schein, Inc. | 0404-9938 | 0404-9938-02 | 1 VIAL in 1 BAG (0404-9938-02) / 2 mL in 1 VIAL |
| PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038 | NDA | Hospira, Inc. | 0409-0155 | 0409-0155-02 | 10 BOTTLE in 1 TRAY (0409-0155-02) / 100 mL in 1 BOTTLE (0409-0155-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | ||||
| Approval Date: | Dec 17, 1999 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Dec 16, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | ||||
| Approval Date: | Mar 13, 2013 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Dec 16, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | 10,016,396 | Patent Expiration: | Jan 4, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 021038
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-001 | Dec 17, 1999 | 6,716,867*PED | ⤷ Subscribe |
| Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-001 | Dec 17, 1999 | 5,344,840 | ⤷ Subscribe |
| Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-004 | Nov 14, 2014 | 6,716,867*PED | ⤷ Subscribe |
| Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-003 | Mar 13, 2013 | 4,910,214*PED | ⤷ Subscribe |
| Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-003 | Mar 13, 2013 | 6,716,867*PED | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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