Diltiazem Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Cantrell Drug Company (2015-06-18)
- Oldest Current Product
- 2006-12-21
- License(s)
- ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
- RxNORM
- INJECTABLE SOLUTION\DILTIAZEM
- FDAOB
- INJECTION\INJECTION\DILTIAZEM HYDROCHLORIDE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\DILTIAZEM HYDROCHLORIDE
INTRAVENOUS\INJECTION\DILTIAZEM HYDROCHLORIDE
INTRAVENOUS\POWDER, FOR SOLUTION\DILTIAZEM HYDROCHLORIDE - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\DILTIAZEM
INTRAVENOUS\INJECTION\DILTIAZEM
INTRAVENOUS\POWDER, FOR SOLUTION\DILTIAZEM
product(s) by strength(s)
diltiazem hydrochloride 0.83 mg/ml injectable solution
product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|---|---|
| 1 | 525330198 | UNAPPROVED DRUG OTHER MARKETING CATEGORY | Cantrell Drug Company | 2013-10-22 | DILTIAZEM HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | 7fc9bee3-9e04-4b3e-a49b-3151d6623a3b |
diltiazem hydrochloride 1 mg/ml injectable solution
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|---|---|
| 1 | 525330103 | UNAPPROVED DRUG OTHER MARKETING CATEGORY | Cantrell Drug Company | 2011-09-30 | DILTIAZEM HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | 193375bf-bbd2-4a59-b051-ceebef53d9d5 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004094350 | ANDA | Hospira, Inc. | 2011-10-20 | DILTIAZEM HYDROCHLORIDE | INTRAVENOUS | POWDER, FOR SOLUTION | ANDA075853 | 875d1ed5-74b7-4494-ccad-96d2eec23c5a |
diltiazem hydrochloride 5 mg/ml injectable solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004091171 | ANDA | Hospira, Inc. | 2012-04-10 | DILTIAZEM HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA074941 | bba03666-ff4f-4bf6-fa92-78e1ec2d9073 |
| 2 | 006416013 | ANDA | West-Ward Pharmaceuticals Corp. | 2008-12-17 | DILTIAZEM HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA078538 | 453b73bd-c52d-4d72-a0b3-47588e723e0b |
| 3 | 006416014 | ANDA | West-Ward Pharmaceuticals Corp. | 2008-12-17 | DILTIAZEM HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA078538 | 453b73bd-c52d-4d72-a0b3-47588e723e0b |
| 4 | 006416015 | ANDA | West-Ward Pharmaceuticals Corp. | 2008-12-17 | DILTIAZEM HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA078538 | 453b73bd-c52d-4d72-a0b3-47588e723e0b |
| 5 | 174780817 | ANDA | Akorn | 2013-11-12 | DILTIAZEM HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA075086 | f5ea3383-5da4-4219-9802-3737a2eaeef4 |
| 6 | 174780837 | ANDA | Akorn | 2013-03-22 | DILTIAZEM HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA075086 | 81c5cf23-a6f8-454a-9575-d01edf49ed34 |
| 7 | 174780937 | ANDA | Akorn | 2006-12-21 | DILTIAZEM HYDROCHLORIDE | INTRAVENOUS | INJECTION | ANDA075086 | 5e36488b-8f2d-4dc9-b803-af1829e6fdd0 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA074617 | DILTIAZEM HYDROCHLORIDE | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 1996-02-28 | ANDA074617_001 | |
| 2 | ANDA074894 | DILTIAZEM HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | 1997-08-26 | ANDA074894_001, ANDA074894_002 | |
| 3 | ANDA074941 | DILTIAZEM HYDROCHLORIDE | HOSPIRA INC | 1998-04-15 | ANDA074941_001 | |
| 4 | ANDA075004 | DILTIAZEM HYDROCHLORIDE | True | HOSPIRA INC | 2000-02-16 | ANDA075004_001 |
| 5 | ANDA075086 | DILTIAZEM HYDROCHLORIDE | AKORN INC | 1998-04-09 | ANDA075086_001 | |
| 6 | ANDA075106 | DILTIAZEM HYDROCHLORIDE | True | HOSPIRA INC | 1999-04-29 | ANDA075106_001 |
| 7 | ANDA075375 | DILTIAZEM HYDROCHLORIDE | True | MYLAN LABORATORIES LTD | 1999-09-30 | ANDA075375_001 |
| 8 | ANDA075749 | DILTIAZEM HYDROCHLORIDE | INTERNATIONAL MEDICATION SYSTEMS LTD | 2001-11-21 | ANDA075749_001 | |
| 9 | ANDA075853 | DILTIAZEM HYDROCHLORIDE | HOSPIRA INC | 2002-12-17 | ANDA075853_001 | |
| 10 | ANDA078538 | DILTIAZEM HYDROCHLORIDE | EUROHEALTH INTERNATIONAL SARL | 2008-12-17 | ANDA078538_001 | |
| 11 | ANDA202651 | DILTIAZEM HYDROCHLORIDE | HIKMA FARMACEUTICA PORTUGAL SA | 2012-08-09 | ANDA202651_001 | |
| 12 | NDA020027 | CARDIZEM | True | BIOVAIL LABORATORIES INTERNATIONAL SRL | 1991-10-24 | NDA020027_001, NDA020027_003 |
| 13 | NDA020792 | CARDIZEM | True | BIOVAIL LABORATORIES INC | 1997-09-05 | NDA020792_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA074617_001 | RX | DILTIAZEM HYDROCHLORIDE (5MG/ML) | INJECTION | True | AP | 1996-02-28 | DILTIAZEM HYDROCHLORIDE |
| 2 | ANDA074894_001 | discontinued | DILTIAZEM HYDROCHLORIDE (5MG/ML) | INJECTION | False | 1997-08-26 | DILTIAZEM HYDROCHLORIDE | |
| 3 | ANDA074894_002 | RX | DILTIAZEM HYDROCHLORIDE (10MG/ML) | INJECTION | True | 2002-04-19 | DILTIAZEM HYDROCHLORIDE | |
| 4 | ANDA074941_001 | RX | DILTIAZEM HYDROCHLORIDE (5MG/ML) | INJECTION | False | AP | 1998-04-15 | DILTIAZEM HYDROCHLORIDE |
| 5 | ANDA075004_001 | discontinued | DILTIAZEM HYDROCHLORIDE (5MG/ML) | INJECTION | False | 2000-02-16 | DILTIAZEM HYDROCHLORIDE | |
| 6 | ANDA075086_001 | RX | DILTIAZEM HYDROCHLORIDE (5MG/ML) | INJECTION | False | AP | 1998-04-09 | DILTIAZEM HYDROCHLORIDE |
| 7 | ANDA075106_001 | discontinued | DILTIAZEM HYDROCHLORIDE (5MG/ML) | INJECTION | False | 1999-04-29 | DILTIAZEM HYDROCHLORIDE | |
| 8 | ANDA075375_001 | discontinued | DILTIAZEM HYDROCHLORIDE (5MG/ML) | INJECTION | False | 1999-09-30 | DILTIAZEM HYDROCHLORIDE | |
| 9 | ANDA075749_001 | RX | DILTIAZEM HYDROCHLORIDE (5MG/ML) | INJECTION | False | AP | 2001-11-21 | DILTIAZEM HYDROCHLORIDE |
| 10 | ANDA075853_001 | RX | DILTIAZEM HYDROCHLORIDE (100MG/VIAL) | INJECTION | True | 2002-12-17 | DILTIAZEM HYDROCHLORIDE | |
| 11 | ANDA078538_001 | RX | DILTIAZEM HYDROCHLORIDE (5MG/ML) | INJECTION | False | AP | 2008-12-17 | DILTIAZEM HYDROCHLORIDE |
| 12 | ANDA202651_001 | RX | DILTIAZEM HYDROCHLORIDE (5MG/ML) | INJECTION | False | AP | 2012-08-09 | DILTIAZEM HYDROCHLORIDE |
| 13 | NDA020027_001 | discontinued | DILTIAZEM HYDROCHLORIDE (5MG/ML) | INJECTION | False | 1991-10-24 | CARDIZEM | |
| 14 | NDA020027_003 | discontinued | DILTIAZEM HYDROCHLORIDE (25MG/VIAL) | INJECTION | False | 1995-08-18 | CARDIZEM | |
| 15 | NDA020792_001 | discontinued | DILTIAZEM HYDROCHLORIDE (100MG/VIAL) | INJECTION | False | 1997-09-05 | CARDIZEM |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 193375bf-bbd2-4a59-b051-ceebef53d9d5 (view SPL) | Diltiazem HCl 125 mg in 5% Dextrose 100 mL Bag 125 mL | prescription | Human Prescription | Cantrell Drug Company | 2015-06-18 | 7 | 525330103 | |
| 2 | 453b73bd-c52d-4d72-a0b3-47588e723e0b (view SPL) | Diltiazem Hydrochloride InjectionRx Only | prescription | Human Prescription | West-Ward Pharmaceuticals Corp. | 2011-10-12 | 1 | 006416013, 006416014, 006416015 | |
| 3 | 5e36488b-8f2d-4dc9-b803-af1829e6fdd0 (view SPL) | Diltiazem Hydrochloride Injection,0.5% (5 mg/mL) | prescription | Human Prescription | Akorn | ANALYSIS, MANUFACTURE, REPACK | 2011-08-01 | 1 | 174780937 |
| 4 | 7fc9bee3-9e04-4b3e-a49b-3151d6623a3b (view SPL) | Diltiazem HCl 250 mg in 5% Dextrose 300 mL Bag | prescription | Human Prescription | Cantrell Drug Company | 2015-01-12 | 2 | 525330198 | |
| 5 | 81c5cf23-a6f8-454a-9575-d01edf49ed34 (view SPL) | Diltiazem Hydrochloride Injection,0.5% (5 mg/mL) | prescription | Human Prescription | Akorn | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2013-03-20 | 1 | 174780837 |
| 6 | 875d1ed5-74b7-4494-ccad-96d2eec23c5a (view SPL) | Diltiazem Hydrochloride for Injection | prescription | Human Prescription | Hospira, Inc. | 2011-10-20 | 10 | 004094350 | |
| 7 | bba03666-ff4f-4bf6-fa92-78e1ec2d9073 (view SPL) | DILTIAZEM HYDROCHLORIDEINJECTION | prescription | Human Prescription | Hospira, Inc. | 2012-04-10 | 10 | 004091171 | |
| 8 | f5ea3383-5da4-4219-9802-3737a2eaeef4 (view SPL) | Diltiazem Hydrochloride Injection,0.5% (5 mg/mL) | prescription | Human Prescription | Akorn | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2013-11-11 | 1 | 174780817 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII