Application 202313
- Type
- ANDA
- Sponsor
- EMCURE PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADENOSINE | ADENOSINE | SOLUTION;INTRAVENOUS | 60MG/20ML (3MG/ML) | No | No |
| 002 | ADENOSINE | ADENOSINE | SOLUTION;INTRAVENOUS | 90MG/30ML (3MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-556 | Adenosine | Adenosine | NorthStar Rx LLC | ANDA | Current |
| 16714-997 | Adenosine | Adenosine | NorthStar Rx LLC | ANDA | Current |
| 23155-258 | Adenosine | Adenosine | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-258 | Adenosine | Adenosine | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-258 | Adenosine | Adenosine | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-259 | Adenosine | Adenosine | Heritage Pharmaceuticals Inc. | ANDA | Current |