Application 202584
- Type
- ANDA
- Sponsor
- AILEX PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | TABLET, CHEWABLE, TABLET, CAPSULE;ORAL | 262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70199-021 | HELIDAC Therapy | Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules | Casper Pharma LLC | ANDA | Current |
| 70556-103 | Bismuth Subsalicylate/Metronidazole/Tetracycline Hydrochloride | Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules | Ailex Pharmaceuticals, LLC | ANDA | Current |
| 70556-103 | Bismuth Subsalicylate/Metronidazole/Tetracycline Hydrochloride | Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules | Ailex Pharmaceuticals, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56847 | ORIG | 2018-12-20 |