Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074787
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB No No
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 200MG TABLET;ORAL Prescription AB No No
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 300MG 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
08/03/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74787_Labetalol%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74787ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074787_labetalol_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/03/2011 SUPPL-31 Labeling

Label is not available on this site.

11/25/2008 SUPPL-26 Labeling

Label is not available on this site.

08/05/2002 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/29/2002 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

08/05/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/2002 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/12/2001 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

08/05/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/18/2000 SUPPL-8 Labeling

Label is not available on this site.

01/28/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/25/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/25/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/25/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/25/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/30/1999 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/03/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74787_Labetalol%20Hydrochloride_Prntlbl.pdf

LABETALOL HYDROCHLORIDE

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 211325 CADILA PHARMS LTD
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 211325 CADILA PHARMS LTD
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 211325 CADILA PHARMS LTD
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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