Application 213428
- Type
- ANDA
- Sponsor
- YICHANG HUMANWELL
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 |
|---|---|---|---|---|---|
| 70436-039 | Guanfacine | guanfacine | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-039 | Guanfacine | guanfacine | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-040 | Guanfacine | guanfacine | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-040 | Guanfacine | guanfacine | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-041 | Guanfacine | guanfacine | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-041 | Guanfacine | guanfacine | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-042 | Guanfacine | guanfacine | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-042 | Guanfacine | guanfacine | Slate Run Pharmaceuticals, LLC | ANDA | Current |