Application 202578
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|
| 0378-1061 | Guanfacine Hydrochloride | guanfacine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1061 | Guanfacine Hydrochloride | guanfacine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1062 | Guanfacine Hydrochloride | guanfacine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1062 | Guanfacine Hydrochloride | guanfacine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1063 | Guanfacine Hydrochloride | guanfacine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1063 | Guanfacine Hydrochloride | guanfacine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1065 | Guanfacine Hydrochloride | guanfacine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1065 | Guanfacine Hydrochloride | guanfacine | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10082 | ORIG | 2015-06-04 |