Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072196
Company: GRANATA BIO CORP
Company: GRANATA BIO CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MILOPHENE | CLOMIPHENE CITRATE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/20/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/15/2025 | SUPPL-8 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
MILOPHENE
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOMIPHENE CITRATE | CLOMIPHENE CITRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 219406 | ACCORD HLTHCARE |
| CLOMIPHENE CITRATE | CLOMIPHENE CITRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 216739 | APPCO |
| CLOMIPHENE CITRATE | CLOMIPHENE CITRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 220673 | ASCENT PHARMS INC |
| CLOMIPHENE CITRATE | CLOMIPHENE CITRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 075528 | COSETTE |
| CLOMIPHENE CITRATE | CLOMIPHENE CITRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 219781 | NOVITIUM PHARMA |
| CLOMIPHENE CITRATE | CLOMIPHENE CITRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 216545 | RUBICON RESEARCH |
| MILOPHENE | CLOMIPHENE CITRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 072196 | GRANATA BIO CORP |