Coccidioides immitis spherule Injectable Solution
- Brand(s)
- Spherusol
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Nielsen Biosciences, Inc. (2014-10-08)
- Oldest Current Product
- 2011-07-29
- License(s)
- BLA
- RxNORM
- INJECTABLE SOLUTION\COCCIDIOIDES IMMITIS SPHERULE
- SPL Active
- INTRADERMAL\INJECTION, SOLUTION\COCCIDIOIDES IMMITIS SPHERULE
- SPL Moiety
- INTRADERMAL\INJECTION, SOLUTION\COCCIDIOIDES IMMITIS SPHERULE
product(s) by strength(s)
coccidioides immitis spherule 0.0127 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 595840140 | Spherusol | BLA | Nielsen Biosciences, Inc. | 2011-07-29 | COCCIDIOIDES IMMITIS SPHERULE | INTRADERMAL | INJECTION, SOLUTION | 125354 | 77108624-4771-4886-a3e2-b2625c444d1b |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 125354 | Coccidioides immitis Spherule-Derived Skin Test Antigen Application | 2011-07-29 | Spherusol | CBER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 77108624-4771-4886-a3e2-b2625c444d1b (view SPL) | These highlights do not include all the information needed to use Spherusol safely and effectively. See full prescribing information for Spherusol . Coccidioides immitis Spherule-Derived Skin Test Antigen- Spherusol Solution for Intradermal Injection Initial U.S. Approval: July 2011 Nielsen BioSciences, Inc. U.S. Lic. No. 1903 Mfd. by Allermed Laboratories, Inc. U.S. Lic. No. 0467 | prescription | Human Prescription | Nielsen Biosciences, Inc. | manufacture | 2014-10-08 | 5 | 595840140 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII