Vincristine Injectable Solution
- Brand(s)
- Vincasar
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Hospira Worldwide, Inc. (2014-01-27)
- Oldest Current Product
- 1988-04-19
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\VINCRISTINE
- FDAOB
- INJECTION\INJECTION\VINCRISTINE SULFATE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\VINCRISTINE SULFATE
- SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\VINCRISTINE
product(s) by strength(s)
vincristine sulfate 1 mg/ml injectable solution
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 007034402 | Vincasar | ANDA | Teva Parenteral Medicines, Inc | 2000-05-01 | VINCRISTINE SULFATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA075493 | 01cee93f-3ab9-44fa-8c9a-dd5958fd2db9 |
| 2 | 007034412 | Vincasar | ANDA | Teva Parenteral Medicines, Inc | 2000-05-01 | VINCRISTINE SULFATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA075493 | 01cee93f-3ab9-44fa-8c9a-dd5958fd2db9 |
| 3 | 617030309 | ANDA | Hospira Worldwide, Inc. | 1988-04-19 | VINCRISTINE SULFATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA071484 | 49596de6-ab18-49d1-9e5b-30968fc21c36 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA070411 | VINCRISTINE SULFATE | True | ABRAXIS PHARMACEUTICAL PRODUCTS | 1986-09-10 | ANDA070411_001 |
| 2 | ANDA070867 | VINCREX | True | BRISTOL MYERS SQUIBB | 1988-07-12 | ANDA070867_001 |
| 3 | ANDA070873 | VINCRISTINE SULFATE | True | ABIC LTD | 1987-02-19 | ANDA070873_001 |
| 4 | ANDA071426 | VINCASAR PFS | True | TEVA PARENTERAL MEDICINES INC | 1987-07-17 | ANDA071426_001 |
| 5 | ANDA071484 | VINCRISTINE SULFATE PFS | HOSPIRA WORLDWIDE, INC | 1988-04-19 | ANDA071484_001 | |
| 6 | ANDA071559 | VINCRISTINE SULFATE | True | HOSPIRA INC | 1988-04-11 | ANDA071559_001 |
| 7 | ANDA071560 | VINCRISTINE SULFATE | True | HOSPIRA INC | 1988-04-11 | ANDA071560_001 |
| 8 | ANDA071561 | VINCRISTINE SULFATE | True | HOSPIRA INC | 1988-04-11 | ANDA071561_001 |
| 9 | ANDA075493 | VINCRISTINE SULFATE PFS | TEVA PHARMACEUTICALS USA | 1999-09-01 | ANDA075493_001 | |
| 10 | ANDA076296 | VINCRISTINE SULFATE | True | FRESENIUS KABI USA LLC | 2002-12-20 | ANDA076296_001 |
| 11 | ANDA076401 | VINCRISTINE SULFATE | True | FRESENIUS KABI USA LLC | 2003-10-28 | ANDA076401_001 |
| 12 | NDA014103 | ONCOVIN | True | ELI LILLY AND CO | NDA014103_001, NDA014103_002, NDA014103_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA070411_001 | discontinued | VINCRISTINE SULFATE (1MG/ML) | INJECTION | False | 1986-09-10 | VINCRISTINE SULFATE | |
| 2 | ANDA070867_001 | discontinued | VINCRISTINE SULFATE (5MG/VIAL) | INJECTION | False | 1988-07-12 | VINCREX | |
| 3 | ANDA070873_001 | discontinued | VINCRISTINE SULFATE (1MG/ML) | INJECTION | False | 1987-02-19 | VINCRISTINE SULFATE | |
| 4 | ANDA071426_001 | discontinued | VINCRISTINE SULFATE (1MG/ML) | INJECTION | False | 1987-07-17 | VINCASAR PFS | |
| 5 | ANDA071484_001 | RX | VINCRISTINE SULFATE (1MG/ML) | INJECTION | True | AP | 1988-04-19 | VINCRISTINE SULFATE PFS |
| 6 | ANDA071559_001 | discontinued | VINCRISTINE SULFATE (1MG/VIAL) | INJECTION | False | 1988-04-11 | VINCRISTINE SULFATE | |
| 7 | ANDA071560_001 | discontinued | VINCRISTINE SULFATE (2MG/VIAL) | INJECTION | False | 1988-04-11 | VINCRISTINE SULFATE | |
| 8 | ANDA071561_001 | discontinued | VINCRISTINE SULFATE (5MG/VIAL) | INJECTION | False | 1988-04-11 | VINCRISTINE SULFATE | |
| 9 | ANDA075493_001 | RX | VINCRISTINE SULFATE (1MG/ML) | INJECTION | False | AP | 1999-09-01 | VINCRISTINE SULFATE PFS |
| 10 | ANDA076296_001 | discontinued | VINCRISTINE SULFATE (1MG/ML) | INJECTION | False | 2002-12-20 | VINCRISTINE SULFATE | |
| 11 | ANDA076401_001 | discontinued | VINCRISTINE SULFATE (1MG/ML) | INJECTION | False | 2003-10-28 | VINCRISTINE SULFATE | |
| 12 | NDA014103_001 | discontinued | VINCRISTINE SULFATE (1MG/VIAL) | INJECTION | False | ONCOVIN | ||
| 13 | NDA014103_002 | discontinued | VINCRISTINE SULFATE (5MG/VIAL) | INJECTION | False | ONCOVIN | ||
| 14 | NDA014103_003 | discontinued | VINCRISTINE SULFATE (1MG/ML) | INJECTION | False | 1984-03-07 | ONCOVIN |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 01cee93f-3ab9-44fa-8c9a-dd5958fd2db9 (view SPL) | VINCASAR PFS (vinCRIStine sulfate injection USP) | prescription | Human Prescription | Teva Parenteral Medicines, Inc | 2014-10-22 | 8 | 007034402, 007034412 |
| 2 | 49596de6-ab18-49d1-9e5b-30968fc21c36 (view SPL) | VinCRIStine Sulfate Injection, USP | prescription | Human Prescription | Hospira Worldwide, Inc. | 2014-01-27 | 13 | 617030309 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII