Application 202651
- Type
- ANDA
- Sponsor
- HIKMA FARMACEUTICA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML | No | No |
| 002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | INJECTABLE; INJECTION | 50MG/10ML | No | No |
| 003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | INJECTABLE; INJECTION | 125MG/25ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43409 | ORIG | 2013-02-26 |