Details for New Drug Application (NDA): 211962
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The generic ingredient in VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 211962
Tradename: | VANCOMYCIN HYDROCHLORIDE |
Applicant: | Xellia Pharms Aps |
Ingredient: | vancomycin hydrochloride |
Patents: | 5 |
Suppliers and Packaging for NDA: 211962
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | SOLUTION;INTRAVENOUS | 211962 | NDA | Xellia Pharmaceuticals USA LLC | 70594-041 | 70594-041-02 | 6 BAG in 1 CARTON (70594-041-02) / 100 mL in 1 BAG (70594-041-01) |
VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | SOLUTION;INTRAVENOUS | 211962 | NDA | Xellia Pharmaceuticals USA LLC | 70594-041 | 70594-041-03 | 12 BAG in 1 CARTON (70594-041-03) / 100 mL in 1 BAG (70594-041-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | ||||
Approval Date: | Feb 15, 2019 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 6, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING BACTERIAL INFECTIONS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 6, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING BACTERIAL INFECTIONS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 6, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
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