Isoproterenol Injection
- Brand(s)
- Isuprel
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Hospira, Inc. (2013-09-10)
- Oldest Current Product
- 2010-03-01
- License(s)
- NDA
- RxNORM
- INJECTION\ISOPROTERENOL
- FDAOB
- INJECTION\INJECTION\ISOPROTERENOL HYDROCHLORIDE\rdfq
- SPL Active
- INTRACARDIAC\INJECTION, SOLUTION\ISOPROTERENOL HYDROCHLORIDE
- SPL Moiety
- INTRACARDIAC\INJECTION, SOLUTION\ISOPROTERENOL
product(s) by strength(s)
isoproterenol hydrochloride 0.2 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 004091410 | Isuprel | NDA | Hospira, Inc. | 2012-06-18 | ISOPROTERENOL HYDROCHLORIDE | INTRACARDIAC | INJECTION, SOLUTION | NDA010515 | c4288d64-4f76-44f8-d097-4bd3955f5676 |
| 2 | 004091442 | Isuprel | NDA | Hospira, Inc. | 2013-03-21 | ISOPROTERENOL HYDROCHLORIDE | INTRACARDIAC | INJECTION, SOLUTION | NDA010515 | a58f95fa-18f9-4938-8e3f-f33244f68298 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 525840021 | NDA | General Injecatables & Vaccines, Inc | 2010-03-01 | ISOPROTERENOL HYDROCHLORIDE | INTRACARDIAC | INJECTION, SOLUTION | 004091410 | NDA010515 | c099ecdc-d636-43d4-8298-eb43073c41a9 | |
| 2 | 551546988 | Isuprel | NDA | Cardinal Health | 2012-06-18 | ISOPROTERENOL HYDROCHLORIDE | INTRACARDIAC | INJECTION, SOLUTION | 004091410 | NDA010515 | 20062322-f9db-4c9b-9da2-7608468f62c9 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 551544729 | Isuprel | NDA | Cardinal Health | 2012-06-18 | ISOPROTERENOL HYDROCHLORIDE | INTRACARDIAC | INJECTION, SOLUTION | 004091410 | NDA010515 | 7db5c78c-0463-4ec9-b237-33f13e2f6460 |
application(s)
| # | id | title | deprecated | applicant | approved drug |
|---|---|---|---|---|---|
| 1 | ANDA083283 | ISOPROTERENOL HYDROCHLORIDE | True | HOSPIRA INC | ANDA083283_001 |
| 2 | ANDA083346 | ISOPROTERENOL HYDROCHLORIDE | True | HOSPIRA INC | ANDA083346_001 |
| 3 | ANDA083431 | ISOPROTERENOL HYDROCHLORIDE | True | ABRAXIS PHARMACEUTICAL PRODUCTS | ANDA083431_001 |
| 4 | ANDA083486 | ISOPROTERENOL HYDROCHLORIDE | True | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | ANDA083486_001 |
| 5 | ANDA083724 | ISOPROTERENOL HYDROCHLORIDE | True | INTERNATIONAL MEDICATION SYSTEM | ANDA083724_001 |
| 6 | NDA010515 | ISUPREL | HOSPIRA INC | NDA010515_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | application |
|---|---|---|---|---|---|---|
| 1 | ANDA083283_001 | discontinued | ISOPROTERENOL HYDROCHLORIDE (0.02MG/ML) | INJECTION | False | ISOPROTERENOL HYDROCHLORIDE |
| 2 | ANDA083346_001 | discontinued | ISOPROTERENOL HYDROCHLORIDE (0.2MG/ML) | INJECTION | False | ISOPROTERENOL HYDROCHLORIDE |
| 3 | ANDA083431_001 | discontinued | ISOPROTERENOL HYDROCHLORIDE (0.2MG/ML) | INJECTION | False | ISOPROTERENOL HYDROCHLORIDE |
| 4 | ANDA083486_001 | discontinued | ISOPROTERENOL HYDROCHLORIDE (0.2MG/ML) | INJECTION | False | ISOPROTERENOL HYDROCHLORIDE |
| 5 | ANDA083724_001 | discontinued | ISOPROTERENOL HYDROCHLORIDE (0.2MG/ML) | INJECTION | False | ISOPROTERENOL HYDROCHLORIDE |
| 6 | NDA010515_001 | RX | ISOPROTERENOL HYDROCHLORIDE (0.2MG/ML) | INJECTION | True | ISUPREL |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 20062322-f9db-4c9b-9da2-7608468f62c9 (view SPL) | ISUPREL | prescription | Human Prescription | Cardinal Health | REPACK | 2013-03-08 | 1 | 551546988 |
| 2 | 743515bf-af8c-4014-9e4a-bf6972811ea1 (view SPL) | Isuprel | prescription | Human Prescription | Valeant Pharmaceuticals North America Llc | MANUFACTURE | 2015-02-01 | 1 | 001874330 |
| 3 | 7db5c78c-0463-4ec9-b237-33f13e2f6460 (view SPL) | ISUPREL | prescription | Human Prescription | Cardinal Health | REPACK | 2013-04-23 | 1 | 551544729 |
| 4 | a58f95fa-18f9-4938-8e3f-f33244f68298 (view SPL) | IsuprelTM | prescription | Human Prescription | Hospira, Inc. | 2013-09-10 | 2 | 004091442 | |
| 5 | abf5e543-36e8-416e-b053-483ddbf4e568 (view SPL) | IsuprelTM | prescription | Human Prescription | Marathon Pharmaceuticals, Llc | 2013-11-18 | 2 | 429980402 | |
| 6 | c099ecdc-d636-43d4-8298-eb43073c41a9 (view SPL) | Isuprel 1:5000 (Isoproterenol Hydrochloride) 0.2 mg/mL Injection, USP 1mL Single Dose Ampule | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2011-04-23 | 2 | 525840021 | |
| 7 | c4288d64-4f76-44f8-d097-4bd3955f5676 (view SPL) | ISUPREL | prescription | Human Prescription | Hospira, Inc. | 2012-06-18 | 12 | 004091410 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII