Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205931
Company: AQUA PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTICLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET;ORAL Prescription AB Yes No
ACTICLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET;ORAL Prescription AB Yes 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
07/25/2014 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205931s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205931Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205931Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2017 SUPPL-3 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205931Orig1s003,208253Orig1s001ltr.pdf
04/26/2016 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205931s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205931Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/26/2016 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205931s002lbl.pdf
07/25/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205931s000lbl.pdf

ACTICLATE

TABLET;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTICLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET;ORAL Prescription Yes AB 205931 AQUA PHARMS LLC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET;ORAL Prescription No AB 209372 AMNEAL PHARMS CO
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET;ORAL Prescription No AB 208818 LUPIN LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET;ORAL Prescription No AB 208765 MAYNE PHARMA INC

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACTICLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET;ORAL Prescription Yes AB 205931 AQUA PHARMS LLC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET;ORAL Prescription No AB 209372 AMNEAL PHARMS CO
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET;ORAL Prescription No AB 208818 LUPIN LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET;ORAL Prescription No AB 208765 MAYNE PHARMA INC

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