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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209556
Company: PAI HOLDINGS PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% LOTION;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
11/21/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209556Orig1s000ltr.pdf

HYDROCORTISONE BUTYRATE

LOTION;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% LOTION;TOPICAL Prescription No AB 210209 LUPIN LTD
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% LOTION;TOPICAL Prescription No AB 209556 PAI HOLDINGS PHARM
LOCOID HYDROCORTISONE BUTYRATE 0.1% LOTION;TOPICAL Prescription Yes AB 022076 BAUSCH
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