Application 090132
- Type
- ANDA
- Sponsor
- SUN PHARM INDUSTRIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 002 | CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 003 | CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | No | No |
| 004 | CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | CAPSULE, EXTENDED RELEASE;ORAL | 80MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-227 | Carvedilol Phosphate | Carvedilol Phosphate | NorthStar RxLLC | ANDA | Current |
| 16714-228 | Carvedilol Phosphate | Carvedilol Phosphate | NorthStar RxLLC | ANDA | Current |
| 16714-229 | Carvedilol Phosphate | Carvedilol Phosphate | NorthStar RxLLC | ANDA | Current |
| 16714-230 | Carvedilol Phosphate | Carvedilol Phosphate | NorthStar RxLLC | ANDA | Current |
| 51407-050 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-050 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-050 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-051 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-051 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-051 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-052 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-052 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-052 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-053 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-053 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-053 | Carvedilol Phosphate | Carvedilol Phosphate | Golden State Medical Supply, Inc. | ANDA | Current |
| 57664-663 | Carvedilol Phosphate | Carvedilol Phosphate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-663 | Carvedilol Phosphate | Carvedilol Phosphate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-664 | Carvedilol Phosphate | Carvedilol Phosphate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-664 | Carvedilol Phosphate | Carvedilol Phosphate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-665 | Carvedilol Phosphate | Carvedilol Phosphate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-665 | Carvedilol Phosphate | Carvedilol Phosphate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-666 | Carvedilol Phosphate | Carvedilol Phosphate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-666 | Carvedilol Phosphate | Carvedilol Phosphate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50342 | ORIG | 2017-11-08 |