Application 209060
- Type
- ANDA
- Sponsor
- SUNNY PHARMTECH INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMINOCAPROIC ACID | AMINOCAPROIC ACID | TABLET;ORAL | 500MG | No | No |
| 002 | AMINOCAPROIC ACID | AMINOCAPROIC ACID | TABLET;ORAL | 1GM | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60687-505 | Aminocaproic Acid | Aminocaproic Acid | American Health Packaging | ANDA | Current |
| 60687-505 | Aminocaproic Acid | Aminocaproic Acid | American Health Packaging | ANDA | Current |
| 60687-505 | Aminocaproic Acid | Aminocaproic Acid | American Health Packaging | ANDA | Current |
| 69680-115 | Aminocaproic Acid | Aminocaproic Acid | Vitruvias Therapeutics | ANDA | Current |
| 69680-115 | Aminocaproic Acid | Aminocaproic Acid | Vitruvias Therapeutics | ANDA | Current |
| 69680-115 | Aminocaproic Acid | Aminocaproic Acid | Vitruvias Therapeutics | ANDA | Current |
| 69680-116 | Aminocaproic Acid | Aminocaproic Acid | Vitruvias Therapeutics | ANDA | Current |
| 69680-116 | Aminocaproic Acid | Aminocaproic Acid | Vitruvias Therapeutics | ANDA | Current |
| 69680-116 | Aminocaproic Acid | Aminocaproic Acid | Vitruvias Therapeutics | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 56867 | ORIG | 2018-12-20 |