Application 020725
- Type
- BLA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 30,000USP UNITS;6,000USP UNITS;19,000USP UNITS | No | No |
| 002 | CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 60,000USP UNITS;12,000USP UNITS;38,000USP UNITS | No | No |
| 003 | CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 120,000USP UNITS;24,000USP UNITS;76,000USP UNITS | No | No |
| 004 | CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 15,000USP UNITS;3,000USP UNITS;9,500USP UNITS | No | No |
| 005 | CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | CAPSULE, DELAYED RELEASE;ORAL | 180,000USP UNITS;36,000USP UNITS;114,000USP UNITS | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0032-1203 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1203 | Creon | Pancrelipase | AbbVie Inc. | NDA | Current |
| 0032-1203 | Creon | Pancrelipase | AbbVie Inc. | NDA | Current |
| 0032-1203 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1203 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1203 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1206 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1206 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1206 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1206 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1206 | Creon | Pancrelipase | AbbVie Inc. | NDA | Current |
| 0032-1206 | Creon | Pancrelipase | AbbVie Inc. | NDA | Current |
| 0032-1212 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1212 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1212 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1212 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1212 | Creon | Pancrelipase | AbbVie Inc. | NDA | Current |
| 0032-1212 | Creon | Pancrelipase | AbbVie Inc. | NDA | Current |
| 0032-1224 | Creon | Pancrelipase | AbbVie Inc. | NDA | Current |
| 0032-1224 | Creon | Pancrelipase | AbbVie Inc. | NDA | Current |
| 0032-1224 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1224 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1224 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-1224 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-3016 | Creon | Pancrelipase | AbbVie Inc. | NDA | Current |
| 0032-3016 | Creon | Pancrelipase | AbbVie Inc. | NDA | Current |
| 0032-3016 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-3016 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-3016 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 0032-3016 | Creon | Pancrelipase | AbbVie Inc. | BLA | Current |
| 17856-1206 | Creon | Pancrelipase | Atlantic Biologicals Corps | NDA | Current |
| 17856-1212 | Creon | Pancrelipase | Atlantic Biologicals Corps | NDA | Current |
| 17856-1224 | Creon | Pancrelipase | Atlantic Biologicals Corps | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77663 | SUPPL | 2024-02-29 |
| 77662 | SUPPL | 2024-02-29 |
| 77653 | SUPPL | 2024-02-29 |
| 71249 | SUPPL | 2022-06-07 |
| 71248 | SUPPL | 2022-06-07 |
| 71208 | SUPPL | 2022-06-03 |
| 66389 | APPL | 2020-03-23 |
| 62261 | SUPPL | 2020-03-23 |
| 62255 | SUPPL | 2020-03-23 |
| 62254 | SUPPL | 2020-03-23 |
| 62232 | SUPPL | 2020-03-23 |
| 58661 | SUPPL | 2020-03-23 |
| 51453 | SUPPL | 2020-03-23 |
| 46120 | SUPPL | 2020-03-23 |
| 41622 | ORIG | 2020-03-23 |
| 35237 | SUPPL | 2020-03-23 |
| 35236 | SUPPL | 2020-03-23 |
| 35235 | SUPPL | 2020-03-23 |
| 35234 | ORIG | 2020-03-23 |
| 25637 | SUPPL | 2020-03-23 |
| 24180 | ORIG | 2020-03-23 |
| 13293 | SUPPL | 2020-03-23 |
| 13292 | SUPPL | 2020-03-23 |
| 13291 | SUPPL | 2020-03-23 |
| 13290 | SUPPL | 2020-03-23 |
| 3211 | SUPPL | 2020-03-23 |
| 3210 | SUPPL | 2020-03-23 |
| 3209 | SUPPL | 2020-03-23 |
| 3208 | SUPPL | 2020-03-23 |
| 3207 | SUPPL | 2020-03-23 |
| 3206 | ORIG | 2020-03-23 |
| 67139 | SUPPL | 1900-01-01 |
| 63534 | ORIG | 1900-01-01 |
| 63533 | ORIG | 1900-01-01 |
| 63229 | ORIG | 1900-01-01 |