Application 050786
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PYLERA | BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | CAPSULE;ORAL | 140MG;125MG;125MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 58914-601 | Pylera | Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride | Allergan, Inc. | NDA | Current |
| 58914-601 | Pylera | Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride | Allergan, Inc. | NDA | Current |
| 58914-601 | Pylera | Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride | Allergan, Inc. | NDA | Current |
| 58914-601 | Pylera | Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride | Allergan, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84335 | SUPPL | 2025-11-28 |
| 84326 | SUPPL | 2025-11-28 |
| 81855 | SUPPL | 2025-04-08 |
| 81787 | SUPPL | 2025-04-02 |
| 79679 | SUPPL | 2024-09-23 |
| 79666 | SUPPL | 2024-09-20 |
| 79027 | SUPPL | 2024-07-09 |
| 79012 | SUPPL | 2024-07-09 |
| 69701 | SUPPL | 2021-12-21 |
| 69614 | SUPPL | 2021-12-17 |
| 66688 | SUPPL | 2021-03-09 |
| 66659 | SUPPL | 2021-03-09 |
| 55893 | SUPPL | 2018-10-11 |
| 55858 | SUPPL | 2018-10-10 |
| 52426 | SUPPL | 2018-02-06 |
| 52095 | SUPPL | 2018-01-30 |
| 48637 | SUPPL | 2017-06-02 |
| 48615 | SUPPL | 2017-06-01 |
| 46998 | SUPPL | 2017-01-27 |
| 46974 | SUPPL | 2017-01-25 |
| 30545 | SUPPL | 2013-01-25 |
| 39335 | SUPPL | 2013-01-24 |
| 8291 | SUPPL | 2011-01-24 |
| 30544 | SUPPL | 2007-05-29 |
| 18248 | SUPPL | 2007-05-29 |
| 42738 | ORIG | 2006-11-22 |
| 30543 | ORIG | 2006-10-02 |