Drugs@FDA: FDA-Approved Drugs
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEGESTROL ACETATE | MEGESTROL ACETATE | 40MG | TABLET;ORAL | Prescription | AB | No | No |
| MEGESTROL ACETATE | MEGESTROL ACETATE | 20MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/30/1995 | 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 |
|---|---|---|---|---|---|
| 07/29/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/18/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/31/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/17/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
MEGESTROL ACETATE
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MEGESTROL ACETATE | MEGESTROL ACETATE | 40MG | TABLET;ORAL | Prescription | No | AB | 074621 | BARR |
| MEGESTROL ACETATE | MEGESTROL ACETATE | 40MG | TABLET;ORAL | Prescription | No | AB | 072423 | STRIDES PHARMA |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MEGESTROL ACETATE | MEGESTROL ACETATE | 20MG | TABLET;ORAL | Prescription | No | AB | 074621 | BARR |
| MEGESTROL ACETATE | MEGESTROL ACETATE | 20MG | TABLET;ORAL | Prescription | No | AB | 072422 | STRIDES PHARMA |