Application 017558
- Type
- NDA
- Sponsor
- HIKMA
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROBINUL | GLYCOPYRROLATE | INJECTABLE;INJECTION | 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0641-6033 | Glycopyrrolate | Glycopyrrolate | West-ward Pharmaceutical Corp. | NDA | Current |
| 0641-6034 | Glycopyrrolate | Glycopyrrolate | West-ward Pharmaceutical Corp. | NDA | Current |
| 0641-6035 | Glycopyrrolate | Glycopyrrolate | West-ward Pharmaceutical Corp. | NDA | Current |
| 0641-6036 | Glycopyrrolate | Glycopyrrolate | West-ward Pharmaceutical Corp. | NDA | Current |
| 0641-6104 | Robinul | Robinul | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0641-6105 | Robinul | Robinul | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0641-6106 | Robinul | Robinul | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0641-6107 | Robinul | Robinul | West-Ward Pharmaceuticals Corp. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85259 | SUPPL | 2026-03-04 |
| 85158 | SUPPL | 2026-02-25 |
| 85085 | SUPPL | 2026-02-20 |
| 85084 | SUPPL | 2026-02-20 |
| 82899 | SUPPL | 2025-07-21 |
| 82884 | SUPPL | 2025-07-17 |
| 79126 | SUPPL | 2024-07-18 |
| 79101 | SUPPL | 2024-07-16 |
| 79096 | SUPPL | 2024-07-15 |
| 54911 | SUPPL | 2018-07-18 |
| 54861 | SUPPL | 2018-07-09 |
| 20078 | ORIG | 2007-02-20 |
| 33305 | SUPPL | 2005-05-27 |
| 642 | SUPPL | 2005-05-27 |
| 13852 | SUPPL | 2004-11-08 |
| 13850 | SUPPL | 2004-11-08 |
| 641 | SUPPL | 2004-11-08 |
| 639 | SUPPL | 2004-11-08 |
| 13851 | SUPPL | 2003-07-06 |
| 640 | SUPPL | 2003-07-06 |