Application 022037
- Type
- NDA
- Sponsor
- SHIRE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INTUNIV | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 1MG BASE | Yes | No |
| 002 | INTUNIV | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 2MG BASE | Yes | No |
| 003 | INTUNIV | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 3MG BASE | Yes | No |
| 004 | INTUNIV | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 54092-513 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-513 | Intuniv | guanfacine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-513 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-513 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-513 | Intuniv | guanfacine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-515 | Intuniv | guanfacine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-515 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-515 | Intuniv | guanfacine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-515 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-515 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-517 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-517 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-517 | Intuniv | guanfacine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-517 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-517 | Intuniv | guanfacine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-519 | Intuniv | guanfacine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-519 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-519 | Intuniv | guanfacine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-519 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-519 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-520 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-520 | Intuniv | guanfacine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 54092-520 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 54092-520 | Intuniv | guanfacine | Shire US Manufacturing Inc. | NDA | Current |
| 64725-0513 | Intuniv | guanfacine | TYA Pharmaceuticals | NDA | Current |
| 64725-0515 | Intuniv | guanfacine | TYA Pharmaceuticals | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61565 | SUPPL | 2020-01-14 |
| 61498 | SUPPL | 2020-01-14 |
| 58512 | SUPPL | 2019-05-02 |
| 58499 | SUPPL | 2019-05-01 |
| 53000 | SUPPL | 2018-03-15 |
| 52878 | SUPPL | 2018-03-08 |
| 50555 | SUPPL | 2017-12-01 |
| 50513 | SUPPL | 2017-11-28 |
| 6741 | SUPPL | 2016-07-12 |
| 16811 | SUPPL | 2016-07-08 |
| 16810 | SUPPL | 2015-03-19 |
| 6740 | SUPPL | 2015-03-19 |
| 38121 | SUPPL | 2014-11-20 |
| 29123 | SUPPL | 2014-11-20 |
| 51938 | SUPPL | 2014-10-17 |
| 38120 | SUPPL | 2013-08-27 |
| 29122 | SUPPL | 2013-08-27 |
| 6739 | SUPPL | 2013-02-25 |
| 16809 | SUPPL | 2013-02-21 |
| 38119 | SUPPL | 2011-06-10 |
| 29121 | SUPPL | 2011-06-10 |
| 38118 | SUPPL | 2011-03-04 |
| 29120 | SUPPL | 2011-03-02 |
| 42396 | ORIG | 2010-07-09 |
| 24235 | ORIG | 2010-07-09 |
| 38117 | ORIG | 2009-10-01 |
| 6738 | ORIG | 2009-09-10 |
| 68898 | ORIG | 1900-01-01 |
| 68897 | ORIG | 1900-01-01 |
| 68896 | ORIG | 1900-01-01 |
| 67203 | ORIG | 1900-01-01 |
| 67202 | ORIG | 1900-01-01 |
| 67201 | ORIG | 1900-01-01 |
| 67149 | ORIG | 1900-01-01 |
| 67147 | ORIG | 1900-01-01 |
| 67145 | ORIG | 1900-01-01 |
| 54116 | ORIG | 1900-01-01 |
| 54115 | ORIG | 1900-01-01 |
| 54114 | ORIG | 1900-01-01 |
| 54113 | ORIG | 1900-01-01 |
| 54112 | ORIG | 1900-01-01 |
| 51167 | SUPPL | 1900-01-01 |
| 51166 | SUPPL | 1900-01-01 |
| 51165 | SUPPL | 1900-01-01 |
| 51164 | SUPPL | 1900-01-01 |
| 51159 | SUPPL | 1900-01-01 |
| 51158 | SUPPL | 1900-01-01 |
| 51156 | SUPPL | 1900-01-01 |