Application 018925
- Type
- NDA
- Sponsor
- EXELA PHARMA SCS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 5MG/2ML (2.5MG/ML) | No | No |
| 002 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 10MG/4ML (2.5MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51662-1442 | VERAPAMIL HCI | VERAPAMIL HCI | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1442 | VERAPAMIL HCI | VERAPAMIL HCI | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51754-0203 | Verapamil Hydrochloride | Verapamil Hydrochloride | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-0203 | Verapamil Hydrochloride | Verapamil Hydrochloride | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-0204 | Verapamil Hydrochloride | Verapamil Hydrochloride | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-0205 | Verapamil Hydrochloride | Verapamil Hydrochloride | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 51754-0205 | Verapamil Hydrochloride | Verapamil Hydrochloride | EXELA PHARMA SCIENCES, LLC | NDA | Current |
| 71872-7048 | Verapamil Hydrochloride | Verapamil Hydrochloride | Medical Purchasing Solutions, LLC | NDA | Current |
| 71872-7048 | Verapamil Hydrochloride | Verapamil Hydrochloride | Medical Purchasing Solutions, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 45912 | SUPPL | 2016-11-22 |
| 45942 | SUPPL | 2016-11-21 |
| 1128 | SUPPL | 2011-11-07 |
| 11363 | SUPPL | 2011-11-04 |
| 33649 | SUPPL | 2010-04-19 |
| 16097 | SUPPL | 2010-04-19 |