Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071611
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG 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
02/29/1988 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
07/30/2013 SUPPL-70 Labeling-Package Insert

Label is not available on this site.

04/11/2013 SUPPL-69 Labeling-Package Insert

Label is not available on this site.

09/24/2012 SUPPL-67 Labeling-Container/Carton Labels

Label is not available on this site.

02/03/2006 SUPPL-40 Manufacturing (CMC)-New Strength

Label is not available on this site.

02/03/2006 SUPPL-39 Labeling

Label is not available on this site.

02/03/2006 SUPPL-38 Manufacturing (CMC)-New Strength

Label is not available on this site.

04/25/2001 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/2000 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

12/23/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/15/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/15/1996 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/15/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/15/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/15/1996 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/15/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/20/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/29/1993 SUPPL-22 Labeling

Label is not available on this site.

03/12/1993 SUPPL-18 Labeling

Label is not available on this site.

03/12/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/29/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/29/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/29/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/23/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/23/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/23/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/23/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/23/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/23/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/23/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/20/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CYCLOBENZAPRINE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 071611 ACTAVIS LABS FL INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 073541 ANDA REPOSITORY
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078643 AUROBINDO PHARMA
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090478 INVAGEN PHARMS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077563 JUBILANT CADISTA
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078048 KVK TECH
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 073144 MYLAN PHARMS INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078218 ORIT LABS LLC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077209 OXFORD PHARMS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 074421 PLIVA
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 077797 PRINSTON INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208170 RUBICON
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 078722 SUN PHARM INDS LTD

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 071611 ACTAVIS LABS FL INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 073541 ANDA REPOSITORY
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078643 AUROBINDO PHARMA
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090478 INVAGEN PHARMS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077563 JUBILANT CADISTA
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078048 KVK TECH
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 073144 MYLAN PHARMS INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078218 ORIT LABS LLC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077209 OXFORD PHARMS
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 077797 PRINSTON INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 208170 RUBICON
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 078722 SUN PHARM INDS LTD

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 071611 ACTAVIS LABS FL INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 077563 JUBILANT CADISTA
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 073144 MYLAN PHARMS INC
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 208170 RUBICON
CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET;ORAL Prescription No AB 078722 SUN PHARM INDS LTD

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