Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075570
Company: PERRIGO NEW YORK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMMONIUM LACTATE AMMONIUM LACTATE EQ 12% BASE LOTION;TOPICAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/23/2004 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075570_s000_AmmoniumTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/09/2009 SUPPL-1 Labeling

Label is not available on this site.

AMMONIUM LACTATE

LOTION;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 LOTION;TOPICAL Prescription No AB 075570 PERRIGO NEW YORK
AMMONIUM LACTATE AMMONIUM LACTATE EQ 12% BASE LOTION;TOPICAL Prescription No AB 076216 TARO
AMMONIUM LACTATE AMMONIUM LACTATE EQ 12% BASE LOTION;TOPICAL Prescription No AB 075575 WATSON LABS INC

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