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Application 076178
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NIZATIDINE | NIZATIDINE | CAPSULE;ORAL | 150MG | No | No |
| 002 | NIZATIDINE | NIZATIDINE | CAPSULE;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0185-0150 | nizatidine | nizatidine | Eon Labs, Inc. | ANDA | Current |
| 0185-0150 | nizatidine | nizatidine | Eon Labs, Inc. | ANDA | Current |
| 0185-0300 | nizatidine | nizatidine | Eon Labs, Inc. | ANDA | Current |
| 0185-0300 | nizatidine | nizatidine | Eon Labs, Inc. | ANDA | Current |
| 21695-375 | nizatidine | nizatidine | Rebel Distributors Corp | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8872 | ORIG | 2003-04-11 |