Application 074145
- Type
- ANDA
- Sponsor
- WATSON LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE | No | No |
| 002 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0591-0444 | Guanfacine | Guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-0444 | Guanfacine | Guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-0453 | Guanfacine | Guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-0453 | Guanfacine | Guanfacine | Actavis Pharma, Inc. | ANDA | Current |
| 68151-0623 | Guanfacine | Guanfacine | Carilion Materials Management | ANDA | Current |
| 70518-1369 | Guanfacine | Guanfacine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1369 | Guanfacine | Guanfacine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1369 | Guanfacine | Guanfacine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1369 | Guanfacine | Guanfacine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1369 | Guanfacine | Guanfacine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1371 | Guanfacine | Guanfacine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1371 | Guanfacine | Guanfacine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1371 | Guanfacine | Guanfacine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1371 | Guanfacine | Guanfacine | REMEDYREPACK INC. | ANDA | Current |