Lorazepam Injection
- Brand(s)
- Ativan
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- West-Ward Pharmaceuticals Corp. (2011-12-06)
- Oldest Current Product
- 1980-07-01
- License(s)
- NDA, ANDA
- RxNORM
- INJECTION\LORAZEPAM
- FDAOB
- INJECTION\INJECTION\LORAZEPAM\rdfq
- SPL Active
- INTRAMUSCULAR\INJECTION, SOLUTION\LORAZEPAM
INTRAMUSCULAR\INJECTION\LORAZEPAM - SPL Moiety
- INTRAMUSCULAR\INJECTION, SOLUTION\LORAZEPAM
INTRAMUSCULAR\INJECTION\LORAZEPAM
product(s) by strength(s)
1 ml lorazepam 2 mg/ml injection
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 006416001 | Ativan | NDA | West-Ward Pharmaceuticals Corp. | 1980-07-25 | LORAZEPAM | INTRAMUSCULAR | INJECTION | NDA018140 | 5fc0e987-61c9-40c4-b0d5-fcea07c8733e |
2 | 006416048 | NDA | West-Ward Pharmaceuticals Corp. | 1980-07-25 | LORAZEPAM | INTRAMUSCULAR | INJECTION | NDA018140 | 4084fa74-9fd2-45ef-9d56-27bfa31d4e46 |
generic product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|
1 | 004096778 | ANDA | Hospira, Inc. | 1994-05-27 | LORAZEPAM | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA074282 | 608a0345-fc9c-4170-4f8d-96dbdd7e566a |
2 | 174780040 | ANDA | Akorn | 1980-07-01 | LORAZEPAM | INTRAMUSCULAR | INJECTION | ANDA075025 | b5b17cde-a94c-4105-871c-54e7d2bd47e8 |
invalid application product(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 548683566 | ANDA | Physicians Total Care, Inc. | 2007-01-10 | LORAZEPAM | INTRAMUSCULAR | INJECTION, SOLUTION | 004091985 | ANDA074300 | 9f495605-0959-442c-8636-9c2d2f93bdff |
relabeler product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 647256044 | NDA | Tya Pharmaceuticals | 1980-07-25 | LORAZEPAM | INTRAMUSCULAR | INJECTION | 006416044 | NDA018140 | a3e2fbad-d850-4bac-9a45-dc1e75e37cab |
1 ml lorazepam 4 mg/ml injection
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 006416003 | Ativan | NDA | West-Ward Pharmaceuticals Corp. | 1980-07-25 | LORAZEPAM | INTRAMUSCULAR | INJECTION | NDA018140 | 5fc0e987-61c9-40c4-b0d5-fcea07c8733e |
2 | 006416045 | NDA | West-Ward Pharmaceuticals Corp. | 1980-07-25 | LORAZEPAM | INTRAMUSCULAR | INJECTION | NDA018140 | e9b54e42-04cf-4c62-90e1-36f7b31a4e81 |
generic product(s)(s)
# | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|
1 | 004096779 | ANDA | Hospira, Inc. | 1994-05-27 | LORAZEPAM | INTRAMUSCULAR | INJECTION, SOLUTION | ANDA074282 | 608a0345-fc9c-4170-4f8d-96dbdd7e566a |
application(s)
application drug(s)
# | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
---|---|---|---|---|---|---|---|---|
1 | ANDA074243_001 | RX | LORAZEPAM (2MG/ML) | INJECTION | False | AP | 1994-04-12 | LORAZEPAM |
2 | ANDA074243_002 | RX | LORAZEPAM (4MG/ML) | INJECTION | False | AP | 1994-04-12 | LORAZEPAM |
3 | ANDA074276_001 | discontinued | LORAZEPAM (2MG/ML) | INJECTION | False | 1994-04-15 | LORAZEPAM | |
4 | ANDA074276_002 | discontinued | LORAZEPAM (4MG/ML) | INJECTION | False | 1994-04-15 | LORAZEPAM | |
5 | ANDA074280_001 | discontinued | LORAZEPAM (2MG/ML) | INJECTION | False | 1994-05-27 | LORAZEPAM | |
6 | ANDA074280_002 | discontinued | LORAZEPAM (4MG/ML) | INJECTION | False | 1994-05-27 | LORAZEPAM | |
7 | ANDA074282_001 | RX | LORAZEPAM (2MG/ML) | INJECTION | False | AP | 1994-05-27 | LORAZEPAM |
8 | ANDA074282_002 | RX | LORAZEPAM (4MG/ML) | INJECTION | False | AP | 1994-05-27 | LORAZEPAM |
9 | ANDA074300_001 | discontinued | LORAZEPAM (2MG/ML) | INJECTION | False | 1994-04-12 | LORAZEPAM | |
10 | ANDA074300_003 | discontinued | LORAZEPAM (4MG/ML) | INJECTION | False | 1997-03-19 | LORAZEPAM | |
11 | ANDA074496_001 | discontinued | LORAZEPAM (2MG/ML) | INJECTION | False | 1998-09-28 | LORAZEPAM | |
12 | ANDA074496_002 | discontinued | LORAZEPAM (4MG/ML) | INJECTION | False | 1998-09-28 | LORAZEPAM | |
13 | ANDA074535_001 | discontinued | LORAZEPAM (2MG/ML) | INJECTION | False | 1996-09-12 | LORAZEPAM | |
14 | ANDA074535_002 | discontinued | LORAZEPAM (4MG/ML) | INJECTION | False | 1996-09-12 | LORAZEPAM | |
15 | ANDA074551_001 | discontinued | LORAZEPAM (2MG/ML) | INJECTION | False | 1996-09-12 | LORAZEPAM | |
16 | ANDA074551_002 | discontinued | LORAZEPAM (4MG/ML) | INJECTION | False | 1996-09-12 | LORAZEPAM | |
17 | ANDA074551_003 | discontinued | LORAZEPAM (1MG/0.5ML) | INJECTION | False | 1996-09-12 | LORAZEPAM | |
18 | ANDA074793_001 | discontinued | LORAZEPAM (2MG/ML) | INJECTION | False | 2000-03-16 | LORAZEPAM | |
19 | ANDA074793_002 | discontinued | LORAZEPAM (4MG/ML) | INJECTION | False | 2000-03-16 | LORAZEPAM | |
20 | ANDA074974_001 | discontinued | LORAZEPAM (2MG/ML) | INJECTION | False | 1998-07-23 | LORAZEPAM | |
21 | ANDA075025_001 | RX | LORAZEPAM (2MG/ML) | INJECTION | False | AP | 1998-07-23 | LORAZEPAM |
22 | ANDA076150_001 | RX | LORAZEPAM (2MG/ML) | INJECTION | False | AP | 2004-11-15 | LORAZEPAM |
23 | ANDA077074_001 | RX | LORAZEPAM (2MG/ML) | INJECTION | False | AP | 2005-07-13 | LORAZEPAM PRESERVATIVE FREE |
24 | ANDA077074_002 | RX | LORAZEPAM (4MG/ML) | INJECTION | False | AP | 2005-07-13 | LORAZEPAM PRESERVATIVE FREE |
25 | ANDA077076_001 | discontinued | LORAZEPAM (2MG/ML) | INJECTION | False | 2005-07-13 | LORAZEPAM | |
26 | ANDA077076_002 | discontinued | LORAZEPAM (4MG/ML) | INJECTION | False | 2005-07-13 | LORAZEPAM | |
27 | NDA018140_001 | RX | LORAZEPAM (2MG/ML) | INJECTION | True | AP | ATIVAN | |
28 | NDA018140_002 | RX | LORAZEPAM (4MG/ML) | INJECTION | True | AP | ATIVAN |
spl(s)
# | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
---|---|---|---|---|---|---|---|---|---|---|
1 | 4084fa74-9fd2-45ef-9d56-27bfa31d4e46 (view SPL) | Lorazepam Injection, USP | prescription | Human Prescription | West-Ward Pharmaceuticals Corp. | ANALYSIS, LABEL, MANUFACTURE | 2011-12-06 | 1 | 006416048, 006416049, 006416050, 006416051 | Lorazepam Injectable Solution |
2 | 5fc0e987-61c9-40c4-b0d5-fcea07c8733e (view SPL) | ATIVANInjection (lorazepam injection, USP) | prescription | Human Prescription | West-Ward Pharmaceuticals Corp. | 2011-11-16 | 2 | 006416001, 006416003, 006416000, 006416002 | Lorazepam Injectable Solution | |
3 | 608a0345-fc9c-4170-4f8d-96dbdd7e566a (view SPL) | LORAZEPAMInjection, USP | prescription | Human Prescription | Hospira, Inc. | 2012-07-10 | 11 | 004096778, 004096779, 004096780, 004096781 | Lorazepam Injectable Solution | |
4 | 9f495605-0959-442c-8636-9c2d2f93bdff (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2010-06-18 | 1 | 548683566 | ||
5 | a3e2fbad-d850-4bac-9a45-dc1e75e37cab (view SPL) | Lorazepam Injection, USP | prescription | Human Prescription | Tya Pharmaceuticals | RELABEL, REPACK | 2011-11-15 | 2 | 647256044 | |
6 | b5b17cde-a94c-4105-871c-54e7d2bd47e8 (view SPL) | LORAZEPAM INJECTION, USP | prescription | Human Prescription | Akorn | ANALYSIS, MANUFACTURE, REPACK | 2014-11-04 | 2 | 174780040 | |
7 | e9b54e42-04cf-4c62-90e1-36f7b31a4e81 (view SPL) | Lorazepam Injection, USP | prescription | Human Prescription | West-Ward Pharmaceuticals Corp. | 2011-11-15 | 2 | 006416045, 006416044, 006416046, 006416047 | Lorazepam Injectable Solution |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII