Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018716
Company: CNTY LINE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANDATE LABETALOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB Yes No
TRANDATE LABETALOL HYDROCHLORIDE 200MG TABLET;ORAL Prescription AB Yes No
TRANDATE LABETALOL HYDROCHLORIDE 300MG TABLET;ORAL Prescription AB Yes No
TRANDATE LABETALOL HYDROCHLORIDE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
08/01/1984 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/27/2016 SUPPL-28 Labeling

Label is not available on this site.

10/27/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/22/2010 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018716s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018716s026ltr.pdf
02/01/2008 SUPPL-25 Labeling

Label is not available on this site.

04/23/2003 SUPPL-23 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18716scm023ltr.pdf
08/13/1998 SUPPL-22 Labeling

Label is not available on this site.

04/21/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/27/1993 SUPPL-20 Labeling

Label is not available on this site.

06/05/1991 SUPPL-19 Labeling

Label is not available on this site.

05/27/1993 SUPPL-18 Labeling

Label is not available on this site.

02/01/1991 SUPPL-17 Labeling

Label is not available on this site.

06/07/1990 SUPPL-16 Labeling

Label is not available on this site.

11/07/1990 SUPPL-15 Labeling

Label is not available on this site.

12/22/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/07/1989 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/16/1989 SUPPL-12 Labeling

Label is not available on this site.

06/16/1989 SUPPL-11 Labeling

Label is not available on this site.

08/27/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/22/1987 SUPPL-9 Labeling

Label is not available on this site.

11/13/1986 SUPPL-8 Labeling

Label is not available on this site.

05/24/1985 SUPPL-6 Labeling

Label is not available on this site.

05/24/1985 SUPPL-5 Labeling

Label is not available on this site.

08/08/1985 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/16/1985 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/26/1985 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/22/2010 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018716s026lbl.pdf

TRANDATE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 074787 HERITAGE PHARMA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 075215 INNOGENIX
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 207863 INVATECH PHARMA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 200908 PAR FORM
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 075113 SANDOZ
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 209603 TWI PHARMS
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 075133 WATSON LABS
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 207743 ZYDUS PHARMS
TRANDATE LABETALOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription Yes AB 018716 CNTY LINE PHARMS

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 074787 HERITAGE PHARMA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 075215 INNOGENIX
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 207863 INVATECH PHARMA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 200908 PAR FORM
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 075113 SANDOZ
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 209603 TWI PHARMS
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 075133 WATSON LABS
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 207743 ZYDUS PHARMS
TRANDATE LABETALOL HYDROCHLORIDE 200MG TABLET;ORAL Prescription Yes AB 018716 CNTY LINE PHARMS

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 074787 HERITAGE PHARMA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 075215 INNOGENIX
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 207863 INVATECH PHARMA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 200908 PAR FORM
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 075113 SANDOZ
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 209603 TWI PHARMS
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 075133 WATSON LABS
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 207743 ZYDUS PHARMS
TRANDATE LABETALOL HYDROCHLORIDE 300MG TABLET;ORAL Prescription Yes AB 018716 CNTY LINE PHARMS

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