Application 207021
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZOLMITRIPTAN | ZOLMITRIPTAN | TABLET;ORAL | 2.5MG | No | No |
| 002 | ZOLMITRIPTAN | ZOLMITRIPTAN | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16571-803 | Zolmitriptan | Zolmitriptan | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-803 | Zolmitriptan | Zolmitriptan | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-804 | Zolmitriptan | Zolmitriptan | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-804 | Zolmitriptan | Zolmitriptan | Rising Pharma Holdings, Inc. | ANDA | Current |
| 65862-914 | Zolmitriptan | Zolmitriptan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-914 | Zolmitriptan | Zolmitriptan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-914 | Zolmitriptan | Zolmitriptan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-915 | Zolmitriptan | Zolmitriptan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-915 | Zolmitriptan | Zolmitriptan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-915 | Zolmitriptan | Zolmitriptan | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10606 | ORIG | 2016-05-16 |