Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074458
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEGESTROL ACETATE | MEGESTROL ACETATE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| MEGESTROL ACETATE | MEGESTROL ACETATE | 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/29/1995 | 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 |
|---|---|---|---|---|---|
| 10/02/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/30/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/20/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/12/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/03/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/24/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
MEGESTROL ACETATE
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 | 074458 | HIKMA |
| MEGESTROL ACETATE | MEGESTROL ACETATE | 20MG | TABLET;ORAL | Prescription | No | AB | 072422 | PAR PHARM |
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 | 074458 | HIKMA |
| MEGESTROL ACETATE | MEGESTROL ACETATE | 40MG | TABLET;ORAL | Prescription | No | AB | 072423 | PAR PHARM |
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