Propranolol Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- West-Ward Pharmaceutical Corp (2015-05-20)
- Oldest Current Product
- 2001-09-07
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\PROPRANOLOL
- FDAOB
- INJECTION\INJECTION\PROPRANOLOL HYDROCHLORIDE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\PROPRANOLOL HYDROCHLORIDE
INTRAVENOUS\INJECTION\PROPRANOLOL HYDROCHLORIDE - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\PROPRANOLOL
INTRAVENOUS\INJECTION\PROPRANOLOL
product(s) by strength(s)
propranolol hydrochloride 1 mg/ml injectable solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001439872 | ANDA | West-Ward Pharmaceutical Corp | 2008-01-31 | PROPRANOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA077760 | 91f2ff1d-68d8-4e83-a2db-618f0410ead7 |
| 2 | 633230604 | ANDA | App Pharmaceuticals, Llc | 2001-09-07 | PROPRANOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA075826 | f14ea537-dd5c-4c78-9037-9a85e9e610ef |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 525840003 | ANDA | General Injecatables & Vaccines, Inc | 2010-08-01 | PROPRANOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | 553900003 | ANDA075792 | 3f412c0c-dfc2-4256-b405-dd4aa2b66e43 |
| 2 | 525840872 | ANDA | General Injecatables & Vaccines, Inc | 2011-02-22 | PROPRANOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | 001439872 | ANDA077760 | d197466a-c6c9-4d47-91f3-5f26b07bb943 |
| 3 | 548683873 | ANDA | Physicians Total Care, Inc. | 2006-12-11 | PROPRANOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | 001439872 | ANDA077760 | d0a8c5d1-bfc1-4829-bbf4-609e05e6d25c |
| 4 | 551545445 | ANDA | Cardinal Health | 2003-02-26 | PROPRANOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | 007813777 | ANDA076400 | 87688f92-a620-437d-904a-25c19d4270c8 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA070135 | PROPRANOLOL HYDROCHLORIDE | True | SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW | 1986-04-15 | ANDA070135_001 |
| 2 | ANDA070136 | PROPRANOLOL HYDROCHLORIDE | True | SOLOPAK MEDICAL PRODUCTS INC | 1986-04-15 | ANDA070136_001 |
| 3 | ANDA070137 | PROPRANOLOL HYDROCHLORIDE | True | SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW | 1986-04-15 | ANDA070137_001 |
| 4 | ANDA075792 | PROPRANOLOL HYDROCHLORIDE | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 2000-08-29 | ANDA075792_001 | |
| 5 | ANDA075826 | PROPRANOLOL HYDROCHLORIDE | FRESENIUS KABI USA LLC | 2001-08-31 | ANDA075826_001 | |
| 6 | ANDA076400 | PROPRANOLOL HYDROCHLORIDE | SANDOZ CANADA INC | 2003-02-26 | ANDA076400_001 | |
| 7 | ANDA077760 | PROPRANOLOL HYDROCHLORIDE | HIKMA FARMACEUTICA (PORTUGAL) SA | 2008-01-31 | ANDA077760_001 | |
| 8 | NDA016419 | PROPRANOLOL HYDROCHLORIDE | BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE | NDA016419_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA070135_001 | discontinued | PROPRANOLOL HYDROCHLORIDE (1MG/ML) | INJECTION | False | 1986-04-15 | PROPRANOLOL HYDROCHLORIDE | |
| 2 | ANDA070136_001 | discontinued | PROPRANOLOL HYDROCHLORIDE (1MG/ML) | INJECTION | False | 1986-04-15 | PROPRANOLOL HYDROCHLORIDE | |
| 3 | ANDA070137_001 | discontinued | PROPRANOLOL HYDROCHLORIDE (1MG/ML) | INJECTION | False | 1986-04-15 | PROPRANOLOL HYDROCHLORIDE | |
| 4 | ANDA075792_001 | RX | PROPRANOLOL HYDROCHLORIDE (1MG/ML) | INJECTION | False | AP | 2000-08-29 | PROPRANOLOL HYDROCHLORIDE |
| 5 | ANDA075826_001 | RX | PROPRANOLOL HYDROCHLORIDE (1MG/ML) | INJECTION | False | AP | 2001-08-31 | PROPRANOLOL HYDROCHLORIDE |
| 6 | ANDA076400_001 | RX | PROPRANOLOL HYDROCHLORIDE (1MG/ML) | INJECTION | False | AP | 2003-02-26 | PROPRANOLOL HYDROCHLORIDE |
| 7 | ANDA077760_001 | RX | PROPRANOLOL HYDROCHLORIDE (1MG/ML) | INJECTION | False | AP | 2008-01-31 | PROPRANOLOL HYDROCHLORIDE |
| 8 | NDA016419_001 | RX | PROPRANOLOL HYDROCHLORIDE (1MG/ML) | INJECTION | True | AP | PROPRANOLOL HYDROCHLORIDE |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 3f412c0c-dfc2-4256-b405-dd4aa2b66e43 (view SPL) | Propranolol HCL 1 mg/mL Injection, USP 1 mL Single Dose Vial | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2010-08-26 | 1 | 525840003 | |
| 2 | 87688f92-a620-437d-904a-25c19d4270c8 (view SPL) | Propranolol Hydrochloride Injection, USP | prescription | Human Prescription | Cardinal Health | REPACK | 2013-04-19 | 1 | 551545445 |
| 3 | 91f2ff1d-68d8-4e83-a2db-618f0410ead7 (view SPL) | PROPRANOLOL HYDROCHLORIDE INJECTION, USP | prescription | Human Prescription | West-Ward Pharmaceutical Corp | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-05-20 | 3 | 001439872 |
| 4 | d0a8c5d1-bfc1-4829-bbf4-609e05e6d25c (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2010-05-27 | 1 | 548683873 | |
| 5 | d197466a-c6c9-4d47-91f3-5f26b07bb943 (view SPL) | Propranolol Hydrochloride Injection, USP 1mg/ml | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2011-02-22 | 1 | 525840872 | |
| 6 | f14ea537-dd5c-4c78-9037-9a85e9e610ef (view SPL) | Propranolol Hydrochloride Injection USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2012-08-30 | 1 | 633230604 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII