NDC 65628-016
FIRVANQ
Vancomycin Hydrochloride
FIRVANQ is a Oral Kit in the Human Prescription Drug category. It is labeled and distributed by Azurity Pharmaceuticals, Inc. The primary component is .
| Product ID | 65628-016_01632ee1-dc04-4afd-a610-56914bc84a42 |
| NDC | 65628-016 |
| Product Type | Human Prescription Drug |
| Proprietary Name | FIRVANQ |
| Generic Name | Vancomycin Hydrochloride |
| Dosage Form | Kit |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-02-14 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208910 |
| Labeler Name | Azurity Pharmaceuticals, Inc |
| Active Ingredient Strength | 0 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 65628-016-05
1 KIT in 1 CARTON (65628-016-05) * 145 mL in 1 BOTTLE * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE
| Marketing Start Date | 2020-02-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 65628-016-05 [65628001605]
FIRVANQ KIT
| Marketing Category | NDA |
| Application Number | NDA208910 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-12-06 |
NDC 65628-016-10 [65628001610]
FIRVANQ KIT
| Marketing Category | NDA |
| Application Number | NDA208910 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-12-06 |
Drug Details
NDC Crossover Matching brand name "FIRVANQ" or generic name "Vancomycin Hydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 65628-208 | FIRVANQ | FIRVANQ |
| 65628-204 | FIRVANQ | FIRVANQ |
| 65628-205 | FIRVANQ | FIRVANQ |
| 65628-206 | FIRVANQ | FIRVANQ |
| 65628-015 | FIRVANQ | FIRVANQ |
| 65628-016 | FIRVANQ | FIRVANQ |
| 0121-0867 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE |
| 0121-0890 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE |
| 0143-9355 | Vancomycin Hydrochloride | Vancomycin Hydrochloride |
| 0143-9356 | Vancomycin Hydrochloride | Vancomycin Hydrochloride |
| 0143-9357 | Vancomycin Hydrochloride | Vancomycin Hydrochloride |
| 0143-9358 | Vancomycin Hydrochloride | Vancomycin Hydrochloride |
| 0143-9359 | Vancomycin Hydrochloride | Vancomycin Hydrochloride |
| 0338-3551 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE |
| 0338-3552 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE |
| 0338-3580 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE |
Trademark Results [FIRVANQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIRVANQ 87715534 5651067 Live/Registered |
CutisPharma, Inc. 2017-12-11 |
 FIRVANQ 87451656 5525903 Live/Registered |
CutisPharma, Inc. 2017-05-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.