Cilastatin / Imipenem Injectable Solution
- Brand(s)
- Primaxin
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Merck Sharp & Dohme Corp. (2014-10-24)
- Oldest Current Product
- 1985-11-26
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\CILASTATIN:IMIPENEM
- FDAOB
- INJECTION\INJECTION\CILASTATIN SODIUM: IMIPENEM\rdfq
INTRAVENOUS\POWDER\CILASTATIN SODIUM: IMIPENEM - SPL Active
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CILASTATIN SODIUM: IMIPENEM
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CILASTATIN: IMIPENEM ANHYDROUS
product(s) by strength(s)
cilastatin 2.5 mg/ml / imipenem 2.5 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000063514 | Primaxin | NDA | Merck Sharp & Dohme Corp. | 1985-11-26 | CILASTATIN SODIUM, IMIPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | NDA050587 | f41d8abd-7792-4918-1b93-bd83ea01955e |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004093508 | ANDA | Hospira, Inc. | 2011-11-17 | CILASTATIN SODIUM, IMIPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA090825 | c2940d3c-762f-4467-97fa-28ba7d2b334b, fe44d24d-55cd-439c-895b-00a38cd59f65 |
invalid application product(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000063551 | Primaxin | ANDA | Merck Sharp & Dohme Corp. | 1987-01-08 | CILASTATIN SODIUM, IMIPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA062756 | f41d8abd-7792-4918-1b93-bd83ea01955e |
cilastatin 5 mg/ml / imipenem 5 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000063516 | Primaxin | NDA | Merck Sharp & Dohme Corp. | 1985-11-26 | CILASTATIN SODIUM, IMIPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | NDA050587 | f41d8abd-7792-4918-1b93-bd83ea01955e |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004093507 | ANDA | Hospira, Inc. | 2011-11-17 | CILASTATIN SODIUM, IMIPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA090825, ANDA091007 | 4b652048-d5e1-48d1-acd4-091c14d9022d, c2940d3c-762f-4467-97fa-28ba7d2b334b, fe44d24d-55cd-439c-895b-00a38cd59f65 |
invalid application product(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000063552 | Primaxin | ANDA | Merck Sharp & Dohme Corp. | 1987-01-08 | CILASTATIN SODIUM, IMIPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA062756 | f41d8abd-7792-4918-1b93-bd83ea01955e | |
| 2 | 551545019 | Primaxin | ANDA | Cardinal Health | 1987-01-08 | CILASTATIN SODIUM, IMIPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | 000063552 | ANDA062756 | 7aa0ce90-156c-4583-ae6d-9ed3595960c8 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 551545030 | Primaxin | NDA | Cardinal Health | 1985-11-26 | CILASTATIN SODIUM, IMIPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | 000063516 | NDA050587 | 7aa0ce90-156c-4583-ae6d-9ed3595960c8 |
| 2 | 551549389 | ANDA | Cardinal Health | 2012-01-03 | CILASTATIN SODIUM, IMIPENEM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | 633230322 | ANDA090577 | 389c2e95-6473-4500-ae8c-93faf15ce68e |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA062756 | PRIMAXIN | True | MERCK AND CO INC | 1987-01-08 | ANDA062756_001, ANDA062756_002 |
| 2 | ANDA090577 | IMIPENEM AND CILASTATIN | ACS DOBFAR SPA | 2011-12-21 | ANDA090577_001, ANDA090577_002 | |
| 3 | ANDA090825 | IMIPENEM AND CILASTATIN | HOSPIRA INC | 2011-11-16 | ANDA090825_001, ANDA090825_002 | |
| 4 | ANDA091007 | IMIPENEM AND CILASTATIN | HOSPIRA INC | 2011-11-16 | ANDA091007_001 | |
| 5 | NDA050587 | PRIMAXIN | MERCK AND CO INC | 1985-11-26 | NDA050587_001, NDA050587_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA062756_001 | discontinued | IMIPENEM (250MG/VIAL), CILASTATIN SODIUM (EQ 250MG BASE/VIAL) | INJECTION | False | 1987-01-08 | PRIMAXIN | ||
| 2 | ANDA062756_002 | discontinued | IMIPENEM (500MG/VIAL), CILASTATIN SODIUM (EQ 500MG BASE/VIAL) | INJECTION | False | 1987-01-08 | PRIMAXIN | ||
| 3 | ANDA090577_001 | RX | IMIPENEM (250MG/VIAL), CILASTATIN SODIUM (EQ 250MG BASE/VIAL) | INTRAVENOUS | POWDER | False | AP | 2011-12-21 | IMIPENEM AND CILASTATIN |
| 4 | ANDA090577_002 | RX | CILASTATIN SODIUM (EQ 500MG BASE/VIAL), IMIPENEM (500MG/VIAL) | INTRAVENOUS | POWDER | False | AP | 2011-12-21 | IMIPENEM AND CILASTATIN |
| 5 | ANDA090825_001 | RX | IMIPENEM (250MG/VIAL), CILASTATIN SODIUM (EQ 250MG BASE/VIAL) | INTRAVENOUS | POWDER | False | AP | 2011-11-16 | IMIPENEM AND CILASTATIN |
| 6 | ANDA090825_002 | RX | IMIPENEM (500MG/VIAL), CILASTATIN SODIUM (EQ 500MG BASE/VIAL) | INTRAVENOUS | POWDER | False | AP | 2011-11-16 | IMIPENEM AND CILASTATIN |
| 7 | ANDA091007_001 | RX | CILASTATIN SODIUM (EQ 500MG BASE/VIAL), IMIPENEM (500MG/VIAL) | INTRAVENOUS | POWDER | False | AP | 2011-11-16 | IMIPENEM AND CILASTATIN |
| 8 | NDA050587_001 | RX | CILASTATIN SODIUM (EQ 250MG BASE/VIAL), IMIPENEM (250MG/VIAL) | INTRAVENOUS | POWDER | True | AP | 1985-11-26 | PRIMAXIN |
| 9 | NDA050587_002 | RX | IMIPENEM (500MG/VIAL), CILASTATIN SODIUM (EQ 500MG BASE/VIAL) | INTRAVENOUS | POWDER | True | AP | 1985-11-26 | PRIMAXIN |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 389c2e95-6473-4500-ae8c-93faf15ce68e (view SPL) | IMIPENEM AND CILASTATIN FOR INJECTION, USP (I.V.) | prescription | Human Prescription | Cardinal Health | REPACK | 2013-04-11 | 2 | 551549389 |
| 2 | 4b652048-d5e1-48d1-acd4-091c14d9022d (view SPL) | IMIPE NEM AND CILASTATIN FOR INJECTION, USP I.V. | prescription | Human Prescription | Hospira, Inc. | 2015-06-22 | 4 | 004093507 | |
| 3 | 7aa0ce90-156c-4583-ae6d-9ed3595960c8 (view SPL) | PRIMAXINI.V.(IMIPENEM AND CILASTATIN FOR INJECTION) | prescription | Human Prescription | Cardinal Health | REPACK | 2013-04-11 | 3 | 551545019, 551545030 |
| 4 | c2940d3c-762f-4467-97fa-28ba7d2b334b (view SPL) | IMIPENEM AND CILASTATIN FOR INJECTION, USP (I.V.) | prescription | Human Prescription | Hospira, Inc. | 2014-07-15 | 23 | 004093507, 004093508 | |
| 5 | f41d8abd-7792-4918-1b93-bd83ea01955e (view SPL) | PRIMAXINI.V.(IMIPENEM AND CILASTATIN FOR INJECTION) | prescription | Human Prescription | Merck Sharp & Dohme Corp. | MANUFACTURE | 2014-10-24 | 16 | 000063514, 000063516, 000063551, 000063552 |
| 6 | fe44d24d-55cd-439c-895b-00a38cd59f65 (view SPL) | IMIPENEM AND CILASTATIN FOR INJECTION, USP (I.V.) | prescription | Human Prescription | Hospira, Inc. | 2015-05-20 | 25 | 004093507, 004093508 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII