Application 202645
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 1.5MG | No | No |
| 002 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 3MG | No | No |
| 003 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 6MG | No | No |
| 004 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 9MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-3692 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3692 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3692 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3692 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3693 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3693 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3693 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3693 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3694 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3694 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3694 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3694 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3695 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3695 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3695 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3695 | Paliperidone | Paliperidone | Actavis Pharma, Inc. | ANDA | Current |
| 68151-5041 | Paliperidone | Paliperidone | Carilion Materials Management | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10089 | ORIG | 2015-08-06 |