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Doxycycline Hyclate

ANDA 90134, held by Actavis Elizabeth. Doxycycline Hyclate.

  • First approved: Dec 14, 2011
  • Supplements approved: 8
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below
DateSubmissionStatusDocuments
Dec 14, 2011Original applicationApprovedNone posted

Products

4 strengths and forms
ProductActive ingredientMarketing
Doxycycline HyclateEQ 75MG BASE · tablet, delayed release;oralDoxycycline HyclateRx
Doxycycline HyclateEQ 100MG BASE · tablet, delayed release;oralDoxycycline HyclateRx
Doxycycline HyclateEQ 50MG BASE · tablet, delayed release;oralDoxycycline HyclateRx
Doxycycline HyclateEQ 200MG BASE · tablet, delayed release;oralDoxycycline HyclateRx
All 9 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Apr 12, 2024Supplement 23Labeling · Standard reviewApprovedNone posted
Apr 12, 2024Supplement 26Labeling · Standard reviewApprovedNone posted
Jan 13, 2021Supplement 21Labeling · Standard reviewApprovedNone posted
Mar 27, 2018Supplement 18Labeling · Standard reviewApprovedLetter
Dec 27, 2017Supplement 14Labeling · Standard reviewApprovedNone posted
Dec 27, 2017Supplement 15Labeling · Standard reviewApprovedNone posted
Dec 27, 2017Supplement 17Labeling · Standard reviewApprovedNone posted
Apr 22, 2014Supplement 11Labeling · Standard reviewApprovedNone posted
Dec 14, 2011Original applicationApprovedNone posted

Identifiers

Application
ANDA 90134

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

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