Application 091526
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE | DIPHENHYDRAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 76045-102 | Diphenhydramine Hydrochloride | Diphenhydramine Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-102 | Diphenhydramine Hydrochloride | Diphenhydramine Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-102 | Diphenhydramine Hydrochloride | Diphenhydramine Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39617 | ORIG | 2013-03-26 |