Details for New Drug Application (NDA): 211962
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NDA 211962 describes TYZAVAN, which is a drug marketed by Hikma and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the TYZAVAN profile page.
The generic ingredient in TYZAVAN is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
The generic ingredient in TYZAVAN is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.
Summary for 211962
| Tradename: | TYZAVAN |
| Applicant: | Hikma |
| Ingredient: | vancomycin hydrochloride |
| Patents: | 6 |
Suppliers and Packaging for NDA: 211962
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TYZAVAN | vancomycin hydrochloride | SOLUTION;INTRAVENOUS | 211962 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9466 | 0143-9466-06 | 6 BAG in 1 CARTON (0143-9466-06) / 250 mL in 1 BAG (0143-9466-01) |
| TYZAVAN | vancomycin hydrochloride | SOLUTION;INTRAVENOUS | 211962 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9467 | 0143-9467-06 | 6 BAG in 1 CARTON (0143-9467-06) / 350 mL in 1 BAG (0143-9467-01) |
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: | ⤷ Get Started Free | Patent Expiration: | Nov 6, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING BACTERIAL INFECTIONS | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Nov 6, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING BACTERIAL INFECTIONS | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Nov 6, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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