Application 212319
- Type
- NDA
- Sponsor
- RAFA LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATROPINE (AUTOINJECTOR) | ATROPINE | SOLUTION;INTRAMUSCULAR | EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71053-592 | N/A | Atropine Injection, 2 mg | Rafa Laboratories, Ltd. | NDA | Current |
| 71053-592 | N/A | Atropine Injection, 2 mg | Rafa Laboratories, Ltd. | NDA | Current |
| 71053-592 | N/A | Atropine Injection, 2 mg | Rafa Laboratories, Ltd. | NDA | Current |