ALA-CORT از شرکت CROWN LABS

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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