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Abbreviated New Drug Application (ANDA): 208765
Company: MAYNE PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET;ORAL Prescription AB No No
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET;ORAL 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
06/14/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208765Orig1s000ltr.pdf

DOXYCYCLINE HYCLATE

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 ALMIRALL
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET;ORAL Prescription No AB 211584 AJANTA PHARMA LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET;ORAL Prescription No AB 211744 ALEMBIC PHARMS LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET;ORAL Prescription No AB 209243 APOTEX
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET;ORAL Prescription No AB 214207 EPIC PHARMA LLC
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 ALMIRALL
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET;ORAL Prescription No AB 211584 AJANTA PHARMA LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET;ORAL Prescription No AB 211744 ALEMBIC PHARMS LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET;ORAL Prescription No AB 209243 APOTEX
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET;ORAL Prescription No AB 214207 EPIC PHARMA LLC
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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