Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062992
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
DOXYCYCLINE HYCLATE 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
02/16/1989 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/05/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/05/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

05/05/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

03/25/1996 SUPPL-1 Labeling

Label is not available on this site.

DOXYCYCLINE HYCLATE

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 062569 HIKMA
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 207757 ZYDUS PHARMS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062992 WEST-WARD PHARMS INT

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
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062992 WEST-WARD PHARMS INT

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English