Application Sponsors
| ANDA 084277 | ANI PHARMS INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | METHOCARBAMOL | METHOCARBAMOL |
FDA Submissions
| ORIG | 1 | AP | 1977-03-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1982-07-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1982-07-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1986-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1986-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1985-08-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1985-08-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1987-02-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1987-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1987-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1987-05-18 | |
| LABELING; Labeling | SUPPL | 29 | AP | 1988-04-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1988-09-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1990-06-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1991-08-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1991-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1998-09-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1998-09-22 | |
| LABELING; Labeling | SUPPL | 38 | AP | 1998-09-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1999-08-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1999-08-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2001-04-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2002-11-13 | |
| LABELING; Labeling | SUPPL | 48 | AP | 2007-09-28 | |
Submissions Property Types
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 84277
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METHOCARBAMOL","submission":"METHOCARBAMOL","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)