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Application 212868
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ATROPINE SULFATE | ATROPINE SULFATE | SOLUTION;INTRAVENOUS | 0.25MG/5ML (0.5MG/ML) | No | No |
| 002 | ATROPINE SULFATE | ATROPINE SULFATE | SOLUTION;INTRAVENOUS | 0.5MG/5ML (0.1MG/ML) | No | No |
| 003 | ATROPINE SULFATE | ATROPINE SULFATE | SOLUTION;INTRAVENOUS | 1MG/10ML (0.1MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-483 | ATROPINE SULFATE | ATROPINE SULFATE | Accord Healthcare, Inc., | ANDA | Current |
| 16729-483 | ATROPINE SULFATE | ATROPINE SULFATE | Accord Healthcare, Inc., | ANDA | Current |
| 16729-483 | ATROPINE SULFATE | ATROPINE SULFATE | Accord Healthcare, Inc., | ANDA | Current |
| 16729-483 | ATROPINE SULFATE | ATROPINE SULFATE | Accord Healthcare, Inc., | ANDA | Current |
| 16729-483 | ATROPINE SULFATE | ATROPINE SULFATE | Accord Healthcare, Inc., | ANDA | Current |
| 16729-484 | ATROPINE SULFATE | ATROPINE SULFATE | Accord Healthcare, Inc., | ANDA | Current |
| 16729-484 | ATROPINE SULFATE | ATROPINE SULFATE | Accord Healthcare, Inc., | ANDA | Current |
| 16729-484 | ATROPINE SULFATE | ATROPINE SULFATE | Accord Healthcare, Inc., | ANDA | Current |
| 16729-484 | ATROPINE SULFATE | ATROPINE SULFATE | Accord Healthcare, Inc., | ANDA | Current |
| 16729-484 | ATROPINE SULFATE | ATROPINE SULFATE | Accord Healthcare, Inc., | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68378 | ORIG | 2021-08-16 |