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Application 202811
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LINZESS | LINACLOTIDE | CAPSULE;ORAL | 145MCG | Yes | Yes |
| 002 | LINZESS | LINACLOTIDE | CAPSULE;ORAL | 290MCG | Yes | No |
| 003 | LINZESS | LINACLOTIDE | CAPSULE;ORAL | 72MCG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0456-1201 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1201 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1201 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1201 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1201 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1201 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1202 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1202 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1202 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1202 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1202 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1202 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1203 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1203 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1203 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1203 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1203 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |
| 0456-1203 | Linzess | linaclotide | Allergan, Inc. | NDA | Current |