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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075883
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMMONIUM LACTATE AMMONIUM LACTATE EQ 12% 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
04/10/2003 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075883.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/30/2004 SUPPL-2 Labeling

Label is not available on this site.

AMMONIUM LACTATE

CREAM;TOPICAL; EQ 12% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMMONIUM LACTATE AMMONIUM LACTATE EQ 12% BASE CREAM;TOPICAL Prescription No AB 075774 PADAGIS ISRAEL
AMMONIUM LACTATE AMMONIUM LACTATE EQ 12% BASE CREAM;TOPICAL Prescription No AB 075883 TARO
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