Application Sponsors
| ANDA 211417 | MACLEODS PHARMS LTD | |
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 | 2022-12-21 | STANDARD |
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
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 211417
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-12-21
)
)