Epoprostenol Injectable Solution
- Brand(s)
- Flolan, Veletri
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Teva Parenteral Medicines, Inc (2012-12-19)
- Oldest Current Product
- 1995-12-08
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\EPOPROSTENOL
- FDAOB
- INJECTION\INJECTION\EPOPROSTENOL SODIUM\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\EPOPROSTENOL SODIUM
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\EPOPROSTENOL
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\EPOPROSTENOL SODIUM - SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\EPOPROSTENOL
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\EPOPROSTENOL
product(s) by strength(s)
epoprostenol 0.1 mg/ml injectable solution
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 662150403 | Veletri | NDA | Actelion Pharmaceuticals Us, Inc. | 2010-04-22 | EPOPROSTENOL | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA022260 | df502787-46ec-4dd1-a2c0-be90f6d95a5d |
generic product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|
1 | 007031985 | ANDA | Teva Parenteral Medicines, Inc | 2008-04-23 | EPOPROSTENOL SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA078396 | 56733651-d331-4e69-a6a3-303756ccc53c |
epoprostenol 0.3 mg/ml injectable solution
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 001730519 | Flolan | NDA | Glaxosmithkline Llc | 1995-12-08 | EPOPROSTENOL SODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA020444 | 8e4b636e-ee9c-4111-779d-28c8369d283b |
2 | 662150401 | Veletri | NDA | Actelion Pharmaceuticals Us, Inc. | 2010-04-22 | EPOPROSTENOL SODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA022260 | d669ff68-ddcf-42f6-913c-d8f1aedbd9c4 |
generic product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|
1 | 007031995 | ANDA | Teva Parenteral Medicines, Inc | 2008-04-23 | EPOPROSTENOL SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA078396 | 56733651-d331-4e69-a6a3-303756ccc53c |
application(s)
# | id | title | applicant | approved | patent | approved drug | in other drug docs |
---|---|---|---|---|---|---|---|
1 | ANDA078396 | EPOPROSTENOL SODIUM | TEVA PHARMACEUTICALS USA | 2008-04-23 | ANDA078396_001, ANDA078396_002 | Water Injectable Solution | |
2 | NDA020444 | FLOLAN | GLAXOSMITHKLINE LLC | 1995-09-20 | NDA020444_001, NDA020444_002 | Water Injectable Solution | |
3 | NDA022260 | VELETRI | ACTELION PHARMACEUTICALS LTD | 2008-06-27 | p8318802, SUBSTANCE p8598227 | NDA022260_001, NDA022260_002 | Water Injectable Solution |
application drug(s)
# | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
---|---|---|---|---|---|---|---|---|
1 | ANDA078396_001 | RX | EPOPROSTENOL SODIUM (EQ 0.5MG BASE/VIAL) | INJECTION | False | AP | 2008-04-23 | EPOPROSTENOL SODIUM |
2 | ANDA078396_002 | RX | EPOPROSTENOL SODIUM (EQ 1.5MG BASE/VIAL) | INJECTION | False | AP | 2008-04-23 | EPOPROSTENOL SODIUM |
3 | NDA020444_001 | RX | EPOPROSTENOL SODIUM (EQ 0.5MG BASE/VIAL) | INJECTION | True | AP | 1995-09-20 | FLOLAN |
4 | NDA020444_002 | RX | EPOPROSTENOL SODIUM (EQ 1.5MG BASE/VIAL) | INJECTION | True | AP | 1995-09-20 | FLOLAN |
5 | NDA022260_001 | RX | EPOPROSTENOL SODIUM (EQ 1.5MG BASE/VIAL) | INJECTION | True | 2008-06-27 | VELETRI | |
6 | NDA022260_002 | RX | EPOPROSTENOL SODIUM (EQ 0.5MG BASE/VIAL) | INJECTION | False | 2012-06-28 | VELETRI |
patent(s)
# | id | expiration date | application(s) | in other drug docs |
---|---|---|---|---|
1 | p8318802 (view patent) | 2027-03-15 | NDA022260 | Water Injectable Solution |
2 | p8598227 (view patent) | 2027-02-02 | NDA022260 | Water Injectable Solution |
spl(s)
# | id | title | category | type | labeler | last update | version | product(s) | in other drug docs |
---|---|---|---|---|---|---|---|---|---|
1 | 56733651-d331-4e69-a6a3-303756ccc53c (view SPL) | Epoprostenol Sodium for InjectionPrescribing InformationRx only | prescription | Human Prescription | Teva Parenteral Medicines, Inc | 2012-12-19 | 3 | 007031985, 007031995, 007039258 | Water Injectable Solution |
2 | 8e4b636e-ee9c-4111-779d-28c8369d283b (view SPL) | These highlights do not include all the information needed to use FLOLAN safely and effectively. See full prescribing information for FLOLAN. FLOLAN (epoprostenol sodium) for injection, for intravenous useInitial U.S. Approval: 1995 | prescription | Human Prescription | Glaxosmithkline Llc | 2015-04-21 | 10 | 001730519, 001730517 | |
3 | d669ff68-ddcf-42f6-913c-d8f1aedbd9c4 (view SPL) | These highlights do not include all the information needed to use VELETRI safely and effectively. See full prescribing information for VELETRI. VELETRI (epoprostenol) for Injection Initial U.S. Approval: 1995 | prescription | Human Prescription | Actelion Pharmaceuticals Us, Inc. | 2011-06-01 | 4 | 662150401 | |
4 | df502787-46ec-4dd1-a2c0-be90f6d95a5d (view SPL) | These highlights do not include all the information needed to use VELETRI safely and effectively. See full prescribing information for VELETRI. VELETRI (epoprostenol) for Injection Initial U.S. Approval: 1995 | prescription | Human Prescription | Actelion Pharmaceuticals Us, Inc. | 2012-06-01 | 3 | 662150403, 662150402 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII