Dacarbazine Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Hospira Worldwide, Inc. (2015-05-13)
- Oldest Current Product
- 1998-08-27
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\DACARBAZINE
- FDAOB
- INJECTION\INJECTION\DACARBAZINE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\DACARBAZINE
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\DACARBAZINE
product(s) by strength(s)
dacarbazine 10 mg/ml injectable solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 007035075 | ANDA | Teva Parenteral Medicines, Inc | 1998-08-27 | DACARBAZINE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA075259 | 26e91082-7698-4680-beab-07c47802f0f9 |
| 2 | 617030327 | ANDA | Hospira Worldwide, Inc. | 2001-10-18 | DACARBAZINE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA075940 | 4c7e5795-feba-425d-7ca3-6cb2c3a1c43c |
| 3 | 633230127 | ANDA | App Pharmaceuticals, Llc | 2001-09-07 | DACARBAZINE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA075371 | b6b97e41-5f15-498c-abfb-d8443ea4d216 |
| 4 | 633230128 | ANDA | App Pharmaceuticals, Llc | 2001-09-07 | DACARBAZINE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA075371 | b6b97e41-5f15-498c-abfb-d8443ea4d216 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA070962 | DACARBAZINE | True | ABRAXIS PHARMACEUTICAL PRODUCTS | 1986-08-28 | ANDA070962_001 |
| 2 | ANDA070990 | DACARBAZINE | True | ABRAXIS PHARMACEUTICAL PRODUCTS | 1986-08-28 | ANDA070990_001 |
| 3 | ANDA075259 | DACARBAZINE | TEVA PHARMACEUTICALS USA | 1998-08-27 | ANDA075259_001, ANDA075259_002 | |
| 4 | ANDA075371 | DACARBAZINE | FRESENIUS KABI USA LLC | 1999-08-27 | ANDA075371_001, ANDA075371_002 | |
| 5 | ANDA075812 | DACARBAZINE | EUROHEALTH INTERNATIONAL SARL | 2001-06-15 | ANDA075812_001, ANDA075812_002 | |
| 6 | ANDA075940 | DACARBAZINE | HOSPIRA INC | 2001-10-18 | ANDA075940_001 | |
| 7 | NDA017575 | DTIC-DOME | BAYER HEALTHCARE PHARMACEUTICALS INC | NDA017575_001, NDA017575_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA070962_001 | discontinued | DACARBAZINE (100MG/VIAL) | INJECTION | False | 1986-08-28 | DACARBAZINE | |
| 2 | ANDA070990_001 | discontinued | DACARBAZINE (200MG/VIAL) | INJECTION | False | 1986-08-28 | DACARBAZINE | |
| 3 | ANDA075259_001 | RX | DACARBAZINE (500MG/VIAL) | INJECTION | True | AP | 2000-09-22 | DACARBAZINE |
| 4 | ANDA075259_002 | RX | DACARBAZINE (200MG/VIAL) | INJECTION | False | AP | 1998-08-27 | DACARBAZINE |
| 5 | ANDA075371_001 | RX | DACARBAZINE (100MG/VIAL) | INJECTION | False | AP | 1999-08-27 | DACARBAZINE |
| 6 | ANDA075371_002 | RX | DACARBAZINE (200MG/VIAL) | INJECTION | False | AP | 1999-08-27 | DACARBAZINE |
| 7 | ANDA075812_001 | RX | DACARBAZINE (200MG/VIAL) | INJECTION | False | AP | 2001-06-15 | DACARBAZINE |
| 8 | ANDA075812_002 | RX | DACARBAZINE (500MG/VIAL) | INJECTION | False | AP | 2002-10-31 | DACARBAZINE |
| 9 | ANDA075940_001 | RX | DACARBAZINE (200MG/VIAL) | INJECTION | False | AP | 2001-10-18 | DACARBAZINE |
| 10 | NDA017575_001 | RX | DACARBAZINE (100MG/VIAL) | INJECTION | True | AP | DTIC-DOME | |
| 11 | NDA017575_002 | RX | DACARBAZINE (200MG/VIAL) | INJECTION | True | AP | DTIC-DOME |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 26e91082-7698-4680-beab-07c47802f0f9 (view SPL) | Dacarbazine for Injection USP | prescription | Human Prescription | Teva Parenteral Medicines, Inc | 2015-01-09 | 2 | 007035075 | |
| 2 | 4c7e5795-feba-425d-7ca3-6cb2c3a1c43c (view SPL) | Dacarbazine for Injection, USP | prescription | Human Prescription | Hospira Worldwide, Inc. | 2015-05-13 | 11 | 617030327 | |
| 3 | b6b97e41-5f15-498c-abfb-d8443ea4d216 (view SPL) | Dacarbazine for Injection USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2012-09-04 | 1 | 633230127, 633230128 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII