Details for New Drug Application (NDA): 209575
✉ Email this page to a colleague
NDA 209575 describes NUMBRINO, which is a drug marketed by Omnivium Pharms and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the NUMBRINO profile page.
The generic ingredient in NUMBRINO is cocaine hydrochloride. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cocaine hydrochloride profile page.
The generic ingredient in NUMBRINO is cocaine hydrochloride. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cocaine hydrochloride profile page.
Summary for 209575
| Tradename: | NUMBRINO |
| Applicant: | Omnivium Pharms |
| Ingredient: | cocaine hydrochloride |
| Patents: | 11 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209575
Generic Entry Date for 209575*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;NASAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Medical Subject Heading (MeSH) Categories for 209575
Suppliers and Packaging for NDA: 209575
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NUMBRINO | cocaine hydrochloride | SOLUTION;NASAL | 209575 | NDA | OMNIVIUM PHARMACEUTICALS LLC. | 81665-300 | 81665-300-02 | 1 BOTTLE, GLASS in 1 CARTON (81665-300-02) / 4 mL in 1 BOTTLE, GLASS |
| NUMBRINO | cocaine hydrochloride | SOLUTION;NASAL | 209575 | NDA AUTHORIZED GENERIC | OMNIVIUM PHARMACEUTICALS LLC. | 81665-301 | 81665-301-02 | 1 BOTTLE, GLASS in 1 CARTON (81665-301-02) / 4 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;NASAL | Strength | 4% | ||||
| Approval Date: | Jan 10, 2020 | TE: | RLD: | Yes | |||||
| Patent: | 10,016,407 | Patent Expiration: | Feb 7, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF ADMINISTERING A LOCAL ANESTHETIC PRIOR TO PERFORMING A DIAGNOSTIC OR SURGICAL PROCEDURE ON A SUBJECT WITH HEPATIC OR RENAL IMPAIRMENT | ||||||||
| Patent: | 10,016,407 | Patent Expiration: | Feb 7, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH HEPATIC IMPAIRMENT | ||||||||
| Patent: | 10,016,407 | Patent Expiration: | Feb 7, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH RENAL IMPAIRMENT | ||||||||
Complete Access Available with Subscription
