Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075133
Company: WATSON LABS
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 Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75133ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75133_Labetalol%20Hydrochloride.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/07/2007 SUPPL-11 Labeling

Label is not available on this site.

11/06/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

06/06/2002 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

06/06/2002 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

02/20/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1999 SUPPL-1 Labeling

Label is not available on this site.

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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