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Generated: May 29, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 1 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
| Ingredient-type | Carbapenems |
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
DORIBAX |
doripenem |
INJECTABLE;IV (INFUSION) | 022106 | NDA | Shionogi Inc. | 59630-309 | 59630-309-10 | 10 VIAL, SINGLE-USE in 1 CARTON (59630-309-10) > 10 mL in 1 VIAL, SINGLE-USE (59630-309-01) |
DORIBAX |
doripenem |
INJECTABLE;IV (INFUSION) | 022106 | NDA | Shionogi Inc. | 59630-320 | 59630-320-10 | 10 VIAL, SINGLE-USE in 1 CARTON (59630-320-10) > 10 mL in 1 VIAL, SINGLE-USE (59630-320-01) |
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;IV (INFUSION) | Strength | 500MG/VIAL | ||||
| Approval Date: | Oct 12, 2007 | TE: | RLD: | Yes | |||||
| Patent: | 8,247,402 | Patent Expiration: | Mar 30, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;IV (INFUSION) | Strength | 250MG/VIAL | ||||
| Approval Date: | Oct 5, 2010 | TE: | RLD: | Yes | |||||
| Patent: | 8,247,402 | Patent Expiration: | Mar 30, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shionogi Inc | DORIBAX | doripenem | INJECTABLE;IV (INFUSION) | 022106-001 | Oct 12, 2007 | 5,317,016 | ► Subscribe | ||||||||||||||||||||||
Shionogi Inc | DORIBAX | doripenem | INJECTABLE;IV (INFUSION) | 022106-002 | Oct 5, 2010 | 5,317,016 | ► Subscribe | ||||||||||||||||||||||
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