meropenem Injectable Solution
- Brand(s)
- Merrem
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Astrazeneca Pharmaceuticals Lp (2015-04-30)
- Oldest Current Product
- 1996-09-23
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\MEROPENEM
- FDAOB
- INJECTION\INJECTION\MEROPENEM\rdfq
IV (INFUSION)\POWDER\MEROPENEM\rdfq - SPL Active
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\MEROPENEM
INTRAVENOUS\INJECTION, SOLUTION\MEROPENEM: SODIUM CHLORIDE
INTRAVENOUS\INJECTION\MEROPENEM - SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\MEROPENEM ANHYDROUS
INTRAVENOUS\INJECTION, SOLUTION\MEROPENEM ANHYDROUS: SODIUM CATION
INTRAVENOUS\INJECTION\MEROPENEM ANHYDROUS
product(s) by strength(s)
meropenem 10 mg/ml injectable solution
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 002643183 | NDA | B. Braun Medical Inc. | 2015-04-30 | MEROPENEM, SODIUM CHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | NDA202106 | 3b952a55-6ef7-45c8-be21-16eefe37ec2e |
meropenem 20 mg/ml injectable solution
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 002643185 | NDA | B. Braun Medical Inc. | 2015-04-30 | MEROPENEM, SODIUM CHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | NDA202106 | 3b952a55-6ef7-45c8-be21-16eefe37ec2e |
meropenem 50 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003100325 | Merrem | NDA | Astrazeneca Pharmaceuticals Lp | 1996-09-23 | MEROPENEM | INTRAVENOUS | INJECTION | NDA050706 | c15e88d3-d903-4e7a-f683-e29f51afa848 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004093505 | ANDA | Hospira, Inc. | 2010-06-23 | MEROPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA090940 | a27ce7d2-0b75-47e8-9a7e-1e561b603216 |
| 2 | 004093506 | ANDA | Hospira, Inc. | 2010-06-23 | MEROPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA090940 | a27ce7d2-0b75-47e8-9a7e-1e561b603216 |
| 3 | 007813265 | ANDA | Sandoz Inc | 2011-03-29 | MEROPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA091201 | a0fcc561-9566-4223-84b3-baa5cf3e0a20 |
| 4 | 007813267 | ANDA | Sandoz Inc | 2011-03-29 | MEROPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA091201 | a0fcc561-9566-4223-84b3-baa5cf3e0a20 |
| 5 | 633230507 | ANDA | App Pharmaceuticals, Llc | 2011-10-14 | MEROPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA091404 | 12714f80-d6e5-4453-b66c-62f57c16ddfc, 185181e3-c004-4d61-b992-5df94fe57a90, 7a68d899-2678-43a9-a9c1-ef8f916b562f |
| 6 | 633230508 | ANDA | App Pharmaceuticals, Llc | 2011-10-26 | MEROPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA091404 | 12714f80-d6e5-4453-b66c-62f57c16ddfc, 185181e3-c004-4d61-b992-5df94fe57a90, 7a68d899-2678-43a9-a9c1-ef8f916b562f |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 551544744 | ANDA | Cardinal Health | 2010-06-23 | MEROPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | 004093505 | ANDA090940 | b79a4b53-0b1b-4f39-b58c-e7d1d0358f83 |
| 2 | 551547825 | ANDA | Cardinal Health | 2010-06-23 | MEROPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | 004093506 | ANDA090940 | b79a4b53-0b1b-4f39-b58c-e7d1d0358f83 |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | ANDA090940 | MEROPENEM | HOSPIRA INC | 2010-06-22 | ANDA090940_001, ANDA090940_002 |
| 2 | ANDA091201 | MEROPENEM | SANDOZ INC | 2011-03-29 | ANDA091201_001, ANDA091201_002 |
| 3 | ANDA091404 | MEROPENEM | ACS DOBFAR SPA | 2011-10-26 | ANDA091404_001, ANDA091404_002 |
| 4 | NDA050706 | MERREM | ASTRAZENECA UK LTD | 1996-06-21 | NDA050706_001, NDA050706_003 |
| 5 | NDA202106 | MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | B BRAUN MEDICAL INC | 2015-04-30 | NDA202106_001, NDA202106_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA090940_001 | RX | MEROPENEM (500MG/VIAL) | INJECTION | False | AP | 2010-06-22 | MEROPENEM |
| 2 | ANDA090940_002 | RX | MEROPENEM (1GM/VIAL) | INJECTION | False | AP | 2010-06-22 | MEROPENEM |
| 3 | ANDA091201_001 | RX | MEROPENEM (500MG/VIAL) | INJECTION | False | AP | 2011-03-29 | MEROPENEM |
| 4 | ANDA091201_002 | RX | MEROPENEM (1GM/VIAL) | INJECTION | False | AP | 2011-03-29 | MEROPENEM |
| 5 | ANDA091404_001 | RX | MEROPENEM (500MG/VIAL) | INJECTION | False | AP | 2011-10-26 | MEROPENEM |
| 6 | ANDA091404_002 | RX | MEROPENEM (1GM/VIAL) | INJECTION | False | AP | 2011-10-26 | MEROPENEM |
| 7 | NDA050706_001 | RX | MEROPENEM (1GM/VIAL) | INJECTION | True | AP | 1996-06-21 | MERREM |
| 8 | NDA050706_003 | RX | MEROPENEM (500MG/VIAL) | INJECTION | True | AP | 1996-06-21 | MERREM |
| 9 | NDA202106_001 | RX | MEROPENEM (500MG/VIAL) | POWDER | False | 2015-04-30 | MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | |
| 10 | NDA202106_002 | RX | MEROPENEM (1GM/VIAL) | POWDER | False | 2015-04-30 | MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 12714f80-d6e5-4453-b66c-62f57c16ddfc (view SPL) | These highlights do not include all the information needed to use Meropenem for injection (I.V.) safely and effectively. See full prescribing information for Meropenem for injection (I.V.). MEROPENEM FOR INJECTION, USP (I.V.)Initial U.S. Approval: 1996 | prescription | Human Prescription | App Pharmaceuticals, Llc | API MANUFACTURE, MANUFACTURE | 2015-10-08 | 5 | 633230507, 633230508 |
| 2 | 185181e3-c004-4d61-b992-5df94fe57a90 (view SPL) | These highlights do not include all the information needed to use Meropenem for injection (I.V.) safely and effectively. See full prescribing information for Meropenem for injection (I.V.). MEROPENEM FOR INJECTION, USP (I.V.)Initial U.S. Approval: 1996 | prescription | Human Prescription | App Pharmaceuticals, Llc | API MANUFACTURE, MANUFACTURE | 2015-10-04 | 8 | 633230507, 633230508 |
| 3 | 3b952a55-6ef7-45c8-be21-16eefe37ec2e (view SPL) | These highlights do not include all the information needed to use MEROPENEM FOR INJECTION USP AND SODIUM CHLORIDE INJECTION USP safely and effectively. See full prescribing information for MEROPENEM FOR INJECTION USP AND SODIUM CHLORIDE INJECTION USP. MEROPENEM FOR INJECTION USP AND SODIUM CHLORIDE INJECTION USP IN DUPLEX CONTAINER, for intravenous use Initial U.S. Approval: 1996 | prescription | Human Prescription | B. Braun Medical Inc. | 2015-04-30 | 9 | 002643183, 002643185 | |
| 4 | 7a68d899-2678-43a9-a9c1-ef8f916b562f (view SPL) | These highlights do not include all the information needed to use Meropenem for injection (I.V.) safely and effectively. See full prescribing information for Meropenem for injection (I.V.). MEROPENEM FOR INJECTION, USP (I.V.)Initial U.S. Approval: 1996 | prescription | Human Prescription | App Pharmaceuticals, Llc | API MANUFACTURE, MANUFACTURE | 2015-10-04 | 2 | 633230507, 633230508 |
| 5 | a0fcc561-9566-4223-84b3-baa5cf3e0a20 (view SPL) | These highlights do not include all the information needed to use Meropenem for Injection safely and effectively. See full prescribing information for Meropenem for Injection. Meropenem for InjectionInitial U.S. Approval: 1996To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. | prescription | Human Prescription | Sandoz Inc | 2013-04-02 | 17 | 007813265, 007813267 | |
| 6 | a27ce7d2-0b75-47e8-9a7e-1e561b603216 (view SPL) | These highlights do not include all the information needed to use MEROPENEM FOR INJECTION I.V. safely and effectively. See full prescribing information for MEROPENEM FOR INJECTION I.V. MEROPENEM FOR INJECTION, USP (I.V.)Initial U.S. Approval: 1996 | prescription | Human Prescription | Hospira, Inc. | 2015-05-08 | 9 | 004093505, 004093506 | |
| 7 | b79a4b53-0b1b-4f39-b58c-e7d1d0358f83 (view SPL) | These highlights do not include all the information needed to use Meropenem for Injection I.V. safely and effectively. See full prescribing information for Meropenem for Injection I.V. Meropenem for Injection, USP (I.V.) Initial U.S. Approval: 1996 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection I.V. and other antibacterial drugs, Meropenem for Injection I.V. should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. | prescription | Human Prescription | Cardinal Health | REPACK | 2015-05-21 | 2 | 551544744, 551547825 |
| 8 | c15e88d3-d903-4e7a-f683-e29f51afa848 (view SPL) | These highlights do not include all the information needed to use MERREM I.V. safely and effectively. See full prescribing information for MERREM I.V. MERREM I.V. (meropenem for Injection)Initial U.S. Approval: 1996 | prescription | Human Prescription | Astrazeneca Pharmaceuticals Lp | 2015-04-30 | 14 | 003100325, 003100321 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII