Skip to contentApplication 018066
- Type
- NDA
- Sponsor
- CHATTEM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | UNISOM | DOXYLAMINE SUCCINATE | TABLET;ORAL | 25MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 41167-0060 | Unisom SleepTabs | Doxylamine Succinate | Chattem, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72774 | SUPPL | 2022-12-05 |
| 72764 | SUPPL | 2022-12-02 |
| 33410 | SUPPL | 2013-09-24 |
| 14009 | SUPPL | 2013-09-13 |
| 14008 | SUPPL | 2002-05-30 |
| 14007 | SUPPL | 2002-05-30 |