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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213053
Company: ALEMBIC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MUPIROCIN MUPIROCIN CALCIUM EQ 2% BASE CREAM;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
11/16/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213053Orig1s000ltr.pdf

MUPIROCIN

CREAM;TOPICAL; EQ 2% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MUPIROCIN MUPIROCIN CALCIUM EQ 2% BASE CREAM;TOPICAL Prescription No AB 213053 ALEMBIC
MUPIROCIN MUPIROCIN CALCIUM EQ 2% BASE CREAM;TOPICAL Prescription No AB 214811 AMNEAL
MUPIROCIN MUPIROCIN CALCIUM EQ 2% BASE CREAM;TOPICAL Prescription No AB 213076 ENCUBE
MUPIROCIN MUPIROCIN CALCIUM EQ 2% BASE CREAM;TOPICAL Prescription No AB 201587 GLENMARK PHARMS INC
MUPIROCIN MUPIROCIN CALCIUM EQ 2% BASE CREAM;TOPICAL Prescription No AB 207116 TARO
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