Application 008816
- Type
- NDA
- Sponsor
- OAK PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XYLOCAINE | LIDOCAINE HYDROCHLORIDE | JELLY;TOPICAL | 2% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 76478-479 | Xylocaine | Lidocaine Hydrochloride | Oak Pharmaceuticals, Inc. | NDA | Current |
| 76478-479 | Xylocaine | Lidocaine Hydrochloride | Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) | NDA | Current |
| 76478-479 | Xylocaine | Lidocaine Hydrochloride | Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) | NDA | Current |