Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207757
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
DOXYCYCLINE DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
09/28/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

DOXYCYCLINE

INJECTABLE;INJECTION; EQ 100MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXY 100 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062475 FRESENIUS KABI USA
DOXYCYCLINE DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091406 MYLAN LABS LTD
DOXYCYCLINE DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062569 WEST-WARD PHARMS INT
DOXYCYCLINE DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207757 ZYDUS PHARMS

INJECTABLE;INJECTION; EQ 200MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXY 200 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062475 FRESENIUS KABI USA
DOXYCYCLINE DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207757 ZYDUS PHARMS

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