Dipyridamole Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- West-Ward Pharmaceuticals Corp. (2011-09-16)
- Oldest Current Product
- 1996-10-18
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\DIPYRIDAMOLE
- FDAOB
- INJECTION\INJECTION\DIPYRIDAMOLE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\DIPYRIDAMOLE
INTRAVENOUS\INJECTION\DIPYRIDAMOLE - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\DIPYRIDAMOLE
INTRAVENOUS\INJECTION\DIPYRIDAMOLE
product(s) by strength(s)
dipyridamole 5 mg/ml injectable solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 006412569 | ANDA | West-Ward Pharmaceuticals Corp. | 1996-10-18 | DIPYRIDAMOLE | INTRAVENOUS | INJECTION | ANDA074521 | 6093dcd9-82d2-414f-8507-eda22c14f626 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 525840569 | ANDA | General Injecatables & Vaccines, Inc | 2010-09-01 | DIPYRIDAMOLE | INTRAVENOUS | INJECTION, SOLUTION | 006412569 | ANDA074521 | 02e40b4e-80bb-4456-9d16-6f8a2f7ec5f0 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA074521 | DIPYRIDAMOLE | EUROHEALTH INTERNATIONAL SARL | 1996-10-18 | ANDA074521_001 | |
| 2 | ANDA074601 | DIPYRIDAMOLE | True | HOSPIRA WORLDWIDE, INC | 1997-12-19 | ANDA074601_001 |
| 3 | ANDA074939 | DIPYRIDAMOLE | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 1998-04-13 | ANDA074939_001 | |
| 4 | ANDA074952 | DIPYRIDAMOLE | True | TEVA PHARMACEUTICALS USA | 1997-11-26 | ANDA074952_001 |
| 5 | ANDA074956 | DIPYRIDAMOLE | FRESENIUS KABI USA LLC | 1998-09-30 | ANDA074956_001 | |
| 6 | ANDA075769 | DIPYRIDAMOLE | True | MYLAN LABORATORIES LTD | 2002-11-27 | ANDA075769_001 |
| 7 | NDA019817 | IV PERSANTINE | True | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | 1990-12-13 | NDA019817_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA074521_001 | RX | DIPYRIDAMOLE (5MG/ML) | INJECTION | False | AP | 1996-10-18 | DIPYRIDAMOLE |
| 2 | ANDA074601_001 | discontinued | DIPYRIDAMOLE (5MG/ML) | INJECTION | False | 1997-12-19 | DIPYRIDAMOLE | |
| 3 | ANDA074939_001 | RX | DIPYRIDAMOLE (5MG/ML) | INJECTION | True | AP | 1998-04-13 | DIPYRIDAMOLE |
| 4 | ANDA074952_001 | discontinued | DIPYRIDAMOLE (5MG/ML) | INJECTION | False | 1997-11-26 | DIPYRIDAMOLE | |
| 5 | ANDA074956_001 | RX | DIPYRIDAMOLE (5MG/ML) | INJECTION | False | AP | 1998-09-30 | DIPYRIDAMOLE |
| 6 | ANDA075769_001 | discontinued | DIPYRIDAMOLE (5MG/ML) | INJECTION | False | 2002-11-27 | DIPYRIDAMOLE | |
| 7 | NDA019817_001 | discontinued | DIPYRIDAMOLE (5MG/ML) | INJECTION | False | 1990-12-13 | IV PERSANTINE |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 02e40b4e-80bb-4456-9d16-6f8a2f7ec5f0 (view SPL) | Dipyridamole 5 mg/mL Injection, USP 10 mL Single Dose Vial | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2012-02-08 | 2 | 525840569 | |
| 2 | 6093dcd9-82d2-414f-8507-eda22c14f626 (view SPL) | Dipyridamole Injection, USPRx only | prescription | Human Prescription | West-Ward Pharmaceuticals Corp. | MANUFACTURE | 2011-09-16 | 5 | 006412569 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII