Application 202535
- Type
- NDA
- Sponsor
- FERRING PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PREPOPIK | CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE | FOR SOLUTION;ORAL | 12GM/PACKET;3.5GM/PACKET;10MG/PACKET | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55566-9300 | PREPOPIK | SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-9300 | PREPOPIK | SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-9300 | PREPOPIK | SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-9300 | PREPOPIK | SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-9700 | PREPOPIK | SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-9700 | PREPOPIK | SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-9700 | PREPOPIK | SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-9700 | PREPOPIK | SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID | Ferring Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75325 | SUPPL | 2023-08-31 |
| 75324 | SUPPL | 2023-08-31 |
| 75321 | SUPPL | 2023-08-30 |
| 55208 | SUPPL | 2018-08-20 |
| 55189 | SUPPL | 2018-08-16 |
| 55188 | SUPPL | 2018-08-16 |
| 24419 | ORIG | 2012-08-03 |
| 22891 | ORIG | 2012-08-03 |
| 19358 | ORIG | 2012-07-18 |
| 10068 | ORIG | 2012-07-17 |
| 63266 | SUPPL | 1900-01-01 |