Details for New Drug Application (NDA): 209575
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NDA 209575 describes NUMBRINO, which is a drug marketed by Omnivium Pharms and is included in one NDA. It is available from two suppliers. 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. Four 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. Four 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 |
| Formulation / Manufacturing: | see details |
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 AUTHORIZED GENERIC | Lannett Company, Inc. | 0527-1971 | 0527-1971-74 | 1 BOTTLE, GLASS in 1 CARTON (0527-1971-74) / 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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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 | ||||||||
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