Application 213424
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATROPINE SULFATE | ATROPINE SULFATE | SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | 8MG/20ML (0.4MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-512 | Atropine Sulfate | Atropine Sulfate | Accord Healthcare Inc. | ANDA | Current |
| 16729-512 | Atropine Sulfate | Atropine Sulfate | Accord Healthcare Inc. | ANDA | Current |
| 71872-7255 | Atropine Sulfate | Atropine Sulfate | Medical Purchasing Solutions, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67043 | ORIG | 2021-04-13 |