Application 203817
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MESALAMINE | MESALAMINE | TABLET, DELAYED RELEASE;ORAL | 1.2GM | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0591-2245 | Mesalamine | Mesalamine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2245 | Mesalamine | Mesalamine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2245 | Mesalamine | Mesalamine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2245 | Mesalamine | Mesalamine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2245 | Mesalamine | Mesalamine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2245 | Mesalamine | Mesalamine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2245 | Mesalamine | Mesalamine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2245 | Mesalamine | Mesalamine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2245 | Mesalamine | Mesalamine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2245 | Mesalamine | Mesalamine | Actavis Pharma, Inc. | ANDA | Current |
| 42291-564 | Mesalamine | Mesalamine | AvKARE, Inc | ANDA | Current |
| 42291-564 | Mesalamine | Mesalamine | AvKARE | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 50338 | ORIG | 2017-11-08 |