Application 208362
- Type
- ANDA
- Sponsor
- AMRING PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MESALAMINE | MESALAMINE | SUPPOSITORY;RECTAL | 1GM | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69918-560 | Mesalamine Rectal | Mesalamine | Amring Pharmaceuticals Inc. | ANDA | Current |
| 69918-560 | Mesalamine Rectal | Mesalamine | Amring Pharmaceuticals Inc. | ANDA | Current |
| 69918-560 | Mesalamine Rectal | Mesalamine | Amring Pharmaceuticals Inc. | ANDA | Current |
| 69918-560 | Mesalamine Rectal | Mesalamine | Amring Pharmaceuticals Inc. | ANDA | Current |
| 69918-560 | Mesalamine Rectal | Mesalamine | Amring Pharmaceuticals Inc. | ANDA | Current |
| 69918-560 | Mesalamine Rectal | Mesalamine | Amring Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 49580 | ORIG | 2017-08-29 |