Application 212435
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METRONIDAZOLE IN PLASTIC CONTAINER | METRONIDAZOLE | INJECTABLE;INJECTION | 500MG/100ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47335-993 | METRONIDAZOLE | metronidazole | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-993 | METRONIDAZOLE | metronidazole | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 68083-373 | Metronidazole | Metronidazole | Gland Pharma Limited | ANDA | Current |
| 68083-373 | Metronidazole | Metronidazole | Gland Pharma Limited | ANDA | Current |
| 68083-373 | Metronidazole | Metronidazole | Gland Pharma Limited | ANDA | Current |
| 68083-373 | Metronidazole | Metronidazole | Gland Pharma Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64393 | ORIG | 2020-08-24 |