Application 208090
- Type
- NDA
- Sponsor
- COLLEGIUM PHARM INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XTAMPZA ER | OXYCODONE | CAPSULE, EXTENDED RELEASE;ORAL | 9MG | Yes | No |
| 002 | XTAMPZA ER | OXYCODONE | CAPSULE, EXTENDED RELEASE;ORAL | 13.5MG | Yes | No |
| 003 | XTAMPZA ER | OXYCODONE | CAPSULE, EXTENDED RELEASE;ORAL | 18MG | Yes | No |
| 004 | XTAMPZA ER | OXYCODONE | CAPSULE, EXTENDED RELEASE;ORAL | 27MG | Yes | No |
| 005 | XTAMPZA ER | OXYCODONE | CAPSULE, EXTENDED RELEASE;ORAL | 36MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 24510-110 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-110 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-110 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-115 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-115 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-115 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-120 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-120 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-120 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-130 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-130 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-130 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-140 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-140 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 24510-140 | XTAMPZA | OXYCODONE | Collegium Pharmaceutical, Inc. | NDA | Current |
| 55700-557 | XTAMPZA | OXYCODONE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |