Skip to contentApplication 074921
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ESTAZOLAM | ESTAZOLAM | TABLET;ORAL | 1MG | No | No |
| 002 | ESTAZOLAM | ESTAZOLAM | TABLET;ORAL | 2MG | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51862-069 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-069 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-069 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-070 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-070 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-070 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-073 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-073 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-073 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-073 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-074 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-074 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-074 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
| 51862-074 | Estazolam | Estazolam | Mayne Pharma | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43893 | ORIG | 2013-07-01 |