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
ALA-CORT از شرکت CROWN LABS
Abbreviated New Drug Application (ANDA): 080706
Company: CROWN LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALA-CORT | HYDROCORTISONE | 1% | CREAM;TOPICAL | Prescription |
AT |
No | No |
| ALA-CORT | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription |
AT |
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 |
|---|---|---|---|---|---|---|---|
| 03/09/1973 | 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 |
|---|---|---|---|---|---|
| 09/22/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/28/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/22/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/10/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
ALA-CORT
CREAM;TOPICAL; 1%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALA-CORT | HYDROCORTISONE | 1% | CREAM;TOPICAL | Prescription | No | AT | 080706 | CROWN LABS |
| HYDROCORTISONE | HYDROCORTISONE | 1% | CREAM;TOPICAL | Prescription | No | AT | 087795 | ACTAVIS MID ATLANTIC |
| HYDROCORTISONE | HYDROCORTISONE | 1% | CREAM;TOPICAL | Prescription | No | AT | 080693 | FOUGERA PHARMS INC |
CREAM;TOPICAL; 2.5%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALA-CORT | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 080706 | CROWN LABS |
| ANUSOL HC | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 088250 | SALIX PHARMS |
| HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 089682 | ACTAVIS MID ATLANTIC |
| HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 089414 | FOUGERA PHARMS INC |
| HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 040503 | LANNETT CO INC |
| HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 085025 | PADAGIS US |
| HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 040879 | RISING |
| HYDROCORTISONE | HYDROCORTISONE | 2.5% | CREAM;TOPICAL | Prescription | No | AT | 088799 | TARO PHARM INDS LTD |
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