Application 200881
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 1MG BASE | No | No |
| 002 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 2MG BASE | No | No |
| 003 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 3MG BASE | No | No |
| 004 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0228-2850 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2850 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2850 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2850 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2850 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2850 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2850 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2851 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2851 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2851 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2851 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2851 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2851 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2851 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2853 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2853 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2853 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2853 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2853 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2853 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2853 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2855 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2855 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2855 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2855 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2855 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2855 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2855 | guanfacine | guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 42291-324 | guanfacine | guanfacine | AvKARE, Inc. | ANDA | Current |
| 42291-324 | guanfacine | guanfacine | AvKARE, Inc. | ANDA | Current |
| 42291-324 | guanfacine | guanfacine | AvKARE | ANDA | Current |
| 42291-324 | guanfacine | guanfacine | AvKARE | ANDA | Current |
| 42291-325 | guanfacine | guanfacine | AvKARE | ANDA | Current |
| 42291-325 | guanfacine | guanfacine | AvKARE | ANDA | Current |
| 42291-325 | guanfacine | guanfacine | AvKARE, Inc. | ANDA | Current |
| 42291-325 | guanfacine | guanfacine | AvKARE, Inc. | ANDA | Current |
| 42291-326 | guanfacine | guanfacine | AvKARE, Inc. | ANDA | Current |
| 42291-326 | guanfacine | guanfacine | AvKARE, Inc. | ANDA | Current |
| 42291-326 | guanfacine | guanfacine | AvKARE | ANDA | Current |
| 42291-326 | guanfacine | guanfacine | AvKARE | ANDA | Current |
| 42291-327 | guanfacine | guanfacine | AvKARE, Inc. | ANDA | Current |
| 42291-327 | guanfacine | guanfacine | AvKARE, Inc. | ANDA | Current |
| 42291-327 | guanfacine | guanfacine | AvKARE | ANDA | Current |
| 42291-327 | guanfacine | guanfacine | AvKARE | ANDA | Current |
| 63629-7138 | guanfacine | guanfacine | Bryant Ranch Prepack | ANDA | Current |
| 63629-7138 | guanfacine | guanfacine | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32069 | ORIG | 2013-02-26 |