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
BETAMETHASONE VALERATE از شرکت FOUGERA PHARMS INC
New Drug Application (NDA): 018865
Company: FOUGERA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETAMETHASONE VALERATE | BETAMETHASONE VALERATE | EQ 0.1% BASE | OINTMENT;TOPICAL | Prescription |
AB |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/31/1983 | 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 |
|---|---|---|---|---|---|
| 01/20/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/07/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/24/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
BETAMETHASONE VALERATE
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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