Application 208791
- Type
- NDA
- Sponsor
- B BRAUN MEDICAL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CLOROTEKAL | CHLOROPROCAINE HYDROCHLORIDE | SOLUTION;INTRATHECAL | 50MG/5ML (10MG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0264-7055 | Clorotekal | CHLOROPROCAINE HYDROCHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7055 | Clorotekal | CHLOROPROCAINE HYDROCHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7055 | Clorotekal | CHLOROPROCAINE HYDROCHLORIDE | B. Braun Medical Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53078 | ORIG | 2018-03-21 |
| 49875 | ORIG | 2017-09-28 |
| 49869 | ORIG | 2017-09-28 |