Application Sponsors
| ANDA 209165 | ALEMBIC PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | EQ 75MG BASE | 0 | DOXYCYCLINE | DOXYCYCLINE |
| 002 | CAPSULE;ORAL | EQ 100MG BASE | 0 | DOXYCYCLINE | DOXYCYCLINE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-07-28 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2021-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-01-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 7 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ALEMBIC PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 209165
[companyName] => ALEMBIC PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-07-28
)
)