Application 208603
- Type
- NDA
- Sponsor
- ZYLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARYMO ER | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 15MG | Yes | No |
| 002 | ARYMO ER | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 30MG | Yes | No |
| 003 | ARYMO ER | MORPHINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 60MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69344-111 | Arymo | morphine sulfate | Egalet US Inc. | NDA | Current |
| 69344-111 | Arymo | morphine sulfate | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-211 | Arymo | morphine sulfate | Egalet US Inc. | NDA | Current |
| 69344-211 | Arymo | morphine sulfate | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-311 | Arymo | morphine sulfate | Egalet US Inc. | NDA | Current |
| 69344-311 | Arymo | morphine sulfate | Zyla Life Sciences US Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60438 | SUPPL | 2019-10-09 |
| 60437 | SUPPL | 2019-10-09 |
| 60367 | SUPPL | 2019-10-08 |
| 55971 | SUPPL | 2018-10-17 |
| 55914 | SUPPL | 2018-10-15 |
| 55726 | SUPPL | 2018-10-01 |
| 55725 | SUPPL | 2018-10-01 |
| 55521 | SUPPL | 2018-09-19 |
| 55520 | SUPPL | 2018-09-19 |
| 48596 | SUPPL | 2017-05-31 |
| 48029 | ORIG | 2017-04-14 |
| 47517 | ORIG | 2017-03-10 |
| 46807 | ORIG | 2017-01-13 |
| 46731 | ORIG | 2017-01-09 |
| 46728 | ORIG | 2017-01-09 |