Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062432
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG 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
02/15/1983 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
07/28/2017 SUPPL-32 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/30/2015 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

09/02/2014 SUPPL-24 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

12/23/2002 SUPPL-23 Labeling

Label is not available on this site.

02/25/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/06/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/14/1996 SUPPL-20 Labeling

Label is not available on this site.

03/14/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/14/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/22/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/01/1993 SUPPL-15 Labeling

Label is not available on this site.

12/16/1992 SUPPL-14 Labeling

Label is not available on this site.

09/24/1991 SUPPL-13 Labeling

Label is not available on this site.

07/16/1991 SUPPL-12 Labeling

Label is not available on this site.

01/31/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/31/1990 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

DOXYCYCLINE HYCLATE

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 062421 ACTAVIS LABS FL INC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 207773 CADILA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 062269 CARIBE HOLDINGS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 211343 CHANGZHOU PHARM
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 062505 CHARTWELL LIFE SCI
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 209969 EMCURE PHARMS LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 065095 HIKMA INTL PHARMS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 062432 MYLAN
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 207558 NOVEL LABS INC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 062677 SUN PHARM INDUSTRIES

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