Application 204553
- Type
- NDA
- Sponsor
- GATOR PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COLPREP KIT | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | POWDER;ORAL | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10702-283 | ColPrep Kit | sodium sulfate, potassium sulfate, and magnesium sulfate for oral solution | KVK-Tech, Inc. | NDA | Current |