Documents
Application Sponsors
| ANDA 209713 | LUPIN ATLANTIS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Prescription | 006 |
| Prescription | 007 |
| Prescription | 008 |
| Prescription | 009 |
| Prescription | 010 |
| Prescription | 011 |
| Prescription | 012 |
Application Products
| 001 | TABLET;ORAL | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
| 002 | TABLET;ORAL | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
| 003 | TABLET;ORAL | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
| 004 | TABLET;ORAL | 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
| 005 | TABLET;ORAL | 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
| 006 | TABLET;ORAL | 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
| 007 | TABLET;ORAL | 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
| 008 | TABLET;ORAL | 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
| 009 | TABLET;ORAL | 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
| 010 | TABLET;ORAL | 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
| 011 | TABLET;ORAL | 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
| 012 | TABLET;ORAL | 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | 0 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2019-01-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2019-06-03 | UNKNOWN |
Submissions Property Types
TE Codes
| 001 | Prescription | AB1 |
| 002 | Prescription | AB1 |
| 003 | Prescription | AB1 |
| 004 | Prescription | AB1 |
| 005 | Prescription | AB1 |
| 006 | Prescription | AB1 |
| 007 | Prescription | AB1 |
| 008 | Prescription | AB1 |
| 009 | Prescription | AB1 |
| 010 | Prescription | AB1 |
| 011 | Prescription | AB1 |
| 012 | Prescription | AB1 |
CDER Filings
LUPIN
cder:Array
(
[0] => Array
(
[ApplNo] => 209713
[companyName] => LUPIN
[docInserts] => ["",""]
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[labels] =>
[originalApprovals] => [{"actionDate":"01\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-01-18
)
)