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Application 090999
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | APREPITANT | APREPITANT | CAPSULE;ORAL | 40MG | No | No |
| 002 | APREPITANT | APREPITANT | CAPSULE;ORAL | 80MG | No | No |
| 003 | APREPITANT | APREPITANT | CAPSULE;ORAL | 125MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0781-2321 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2321 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2321 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2321 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2321 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2322 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2322 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2322 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2322 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2322 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2323 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2323 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2323 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2323 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-2323 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-4063 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-4063 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-4063 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-4063 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
| 0781-4063 | Aprepitant | aprepitant | Sandoz Inc | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22720 | ORIG | 2013-04-10 |