Documents
Application Sponsors
| NDA 018303 | US PHARMS HOLDINGS I | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 25MG;50MG | 1 | LOPRESSOR HCT | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE |
| 002 | TABLET;ORAL | 25MG;100MG | 1 | LOPRESSOR HCT | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE |
| 003 | TABLET;ORAL | 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LOPRESSOR HCT | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1984-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1985-02-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1985-10-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1988-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1988-09-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1988-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1990-06-14 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1991-09-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1991-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1995-02-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-07-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-03-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1996-06-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-01-08 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1997-11-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1999-02-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1999-04-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2000-05-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2000-05-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2001-07-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2002-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2002-04-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2002-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2003-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2006-09-07 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2008-01-08 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2008-07-24 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2009-08-07 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2011-03-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 36 | AP | 2011-03-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 40 | AP | 2022-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2020-08-20 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 41 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 18303
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)