Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063067
Company: CNTY LINE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DYNACIN MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription AB No No
DYNACIN MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription AB No No
DYNACIN MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;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
07/31/1990 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
12/23/2014 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

08/04/2003 SUPPL-24 Labeling

Label is not available on this site.

09/15/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/15/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/15/1999 SUPPL-15 Labeling

Label is not available on this site.

09/15/1999 SUPPL-14 Manufacturing (CMC)-New Strength

Label is not available on this site.

12/02/1999 SUPPL-13 Labeling

Label is not available on this site.

12/02/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/24/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/14/1997 SUPPL-10 Labeling

Label is not available on this site.

04/24/1996 SUPPL-9 Labeling

Label is not available on this site.

06/24/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/24/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/24/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/07/1994 SUPPL-5 Labeling

Label is not available on this site.

12/21/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/13/1993 SUPPL-3 Labeling

Label is not available on this site.

03/16/1992 SUPPL-2 Labeling

Label is not available on this site.

09/30/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DYNACIN

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DYNACIN MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 063067 CNTY LINE PHARMS
MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription Yes AB 050649 BAUSCH
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 065470 AUROBINDO PHARMA
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 065005 IMPAX LABS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 090867 SUN PHARM INDS INC
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 065062 TORRENT
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 063065 WATSON LABS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 063009 ZYDUS

CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DYNACIN MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 063067 CNTY LINE PHARMS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 065470 AUROBINDO PHARMA
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 065005 IMPAX LABS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 090867 SUN PHARM INDS INC
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 065062 TORRENT
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 063065 WATSON LABS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 063009 ZYDUS

CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DYNACIN MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 063067 CNTY LINE PHARMS
MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription Yes AB 050649 BAUSCH
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 065470 AUROBINDO PHARMA
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 065005 IMPAX LABS
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 090867 SUN PHARM INDS INC
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 065062 TORRENT
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 063181 WATSON LABS TEVA
MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 063011 ZYDUS

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