Application 075718
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FAMOTIDINE | FAMOTIDINE | TABLET;ORAL | 20MG | No | No |
| 002 | FAMOTIDINE | FAMOTIDINE | TABLET;ORAL | 40MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-7193 | Famotidine | Famotidine | Major Pharmaceuticals | ANDA | Current |
| 0904-7193 | Famotidine | Famotidine | Major Pharmaceuticals | ANDA | Current |
| 50268-299 | Famotidine | Famotidine | AvPAK | ANDA | Current |
| 55111-119 | Famotidine | Famotidine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-119 | Famotidine | Famotidine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-120 | Famotidine | Famotidine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-120 | Famotidine | Famotidine | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 63739-325 | FAMOTIDINE | Famotidine | McKesson Corporation | ANDA | Current |
| 68071-2678 | Famotidine | Famotidine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68151-0184 | Famotidine | Famotidine | Carilion Materials Management | ANDA | Current |
| 68645-594 | Famotidine | Famotidine | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68788-9220 | Famotidine | Famotidine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71335-1950 | Famotidine | Famotidine | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 30998 | ORIG | 2001-04-16 |