اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BETA-VAL از شرکت COSETTE
Abbreviated New Drug Application (ANDA): 070069
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BETA-VAL | BETAMETHASONE VALERATE | EQ 0.1% BASE | OINTMENT;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
12/19/1985 | 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 |
---|---|---|---|---|---|
08/30/2001 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
06/13/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/31/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/13/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/25/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/18/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/14/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
02/14/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
BETA-VAL
OINTMENT;TOPICAL; EQ 0.1% BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BETA-VAL | BETAMETHASONE VALERATE | EQ 0.1% BASE | OINTMENT;TOPICAL | Prescription | No | AB | 070069 | COSETTE |
BETAMETHASONE VALERATE | BETAMETHASONE VALERATE | EQ 0.1% BASE | OINTMENT;TOPICAL | Prescription | No | AB | 070051 | ACTAVIS MID ATLANTIC |
BETAMETHASONE VALERATE | BETAMETHASONE VALERATE | EQ 0.1% BASE | OINTMENT;TOPICAL | Prescription | Yes | AB | 018865 | FOUGERA PHARMS INC |
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