Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLDOPA | METHYLDOPA | 250MG | 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 |
---|---|---|---|---|---|---|---|
04/18/1985 | 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 |
---|---|---|---|---|---|
08/04/2004 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
06/25/1999 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
01/19/2000 | SUPPL-29 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
03/22/1999 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/25/1998 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
07/30/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/25/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/05/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/20/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
10/29/1993 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/19/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
07/16/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/16/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/16/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/16/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
07/16/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/17/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
01/31/1990 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/05/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
07/01/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/01/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/09/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/22/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/17/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
METHYLDOPA
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLDOPA | METHYLDOPA | 250MG | TABLET;ORAL | Prescription | No | AB | 070075 | MYLAN |