Amphotericin B Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- X-Gen Pharmaceuticals, Inc. (2011-11-22)
- Oldest Current Product
- 1992-04-29
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\AMPHOTERICIN B
- FDAOB
- INJECTION\INJECTION\AMPHOTERICIN B\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AMPHOTERICIN B
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AMPHOTERICIN B
product(s) by strength(s)
amphotericin b 5 mg/ml injectable solution
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 398221055 | ANDA | X-Gen Pharmaceuticals, Inc. | 1992-04-29 | AMPHOTERICIN B | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA063206 | a0a54943-9ce4-4f3e-b681-a1a9144c16ce |
| # | id | title | deprecated | applicant | approved | approved drug |
|---|
| 1 | ANDA060517 | FUNGIZONE | True | APOTHECON INC DIV BRISTOL MYERS SQUIBB | | ANDA060517_001 |
| 2 | ANDA062728 | AMPHOTERICIN B | True | ABRAXIS PHARMACEUTICAL PRODUCTS | 1987-04-13 | ANDA062728_001 |
| 3 | ANDA063206 | AMPHOTERICIN B | | X GEN PHARMACEUTICALS INC | 1992-04-29 | ANDA063206_001 |
| 4 | ANDA064062 | AMPHOTERICIN B | True | TEVA PARENTERAL MEDICINES INC | 1995-03-31 | ANDA064062_001 |
| 5 | ANDA064141 | AMPHOTERICIN B | True | ABBOTT LABORATORIES | 1996-12-23 | ANDA064141_001 |
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|
| 1 | ANDA060517_001 | discontinued | AMPHOTERICIN B (50MG/VIAL) | INJECTION | False | | FUNGIZONE |
| 2 | ANDA062728_001 | discontinued | AMPHOTERICIN B (50MG/VIAL) | INJECTION | False | 1987-04-13 | AMPHOTERICIN B |
| 3 | ANDA063206_001 | RX | AMPHOTERICIN B (50MG/VIAL) | INJECTION | True | 1992-04-29 | AMPHOTERICIN B |
| 4 | ANDA064062_001 | discontinued | AMPHOTERICIN B (50MG/VIAL) | INJECTION | False | 1995-03-31 | AMPHOTERICIN B |
| 5 | ANDA064141_001 | discontinued | AMPHOTERICIN B (50MG/VIAL) | INJECTION | False | 1996-12-23 | AMPHOTERICIN B |
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|
| 1 | a0a54943-9ce4-4f3e-b681-a1a9144c16ce (view SPL) | Amphotericin B for Injection USP Rx Only FOR INTRAMUSCULAR AND INTRAVENOUS USE | prescription | Human Prescription | X-Gen Pharmaceuticals, Inc. | 2011-11-22 | 10 | 398221055 |