Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073457
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription AB No No
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription AB No No
ATENOLOL ATENOLOL 50MG 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
01/24/1992 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
07/01/2015 SUPPL-35 Labeling-Container/Carton Labels

Label is not available on this site.

12/12/2005 SUPPL-26 Labeling

Label is not available on this site.

02/06/2004 SUPPL-24 Labeling

Label is not available on this site.

10/28/2003 SUPPL-23 Labeling

Label is not available on this site.

01/03/2003 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2001 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/10/2000 SUPPL-19 Labeling

Label is not available on this site.

06/07/2000 SUPPL-18 Labeling

Label is not available on this site.

04/05/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/25/1999 SUPPL-16 Labeling

Label is not available on this site.

04/26/1999 SUPPL-15 Labeling

Label is not available on this site.

04/26/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/26/1999 SUPPL-12 Manufacturing (CMC)-New Strength

Label is not available on this site.

08/14/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/13/1997 SUPPL-9 Labeling

Label is not available on this site.

10/30/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/29/1994 SUPPL-7 Labeling

Label is not available on this site.

08/31/1993 SUPPL-6 Labeling

Label is not available on this site.

02/08/1993 SUPPL-4 Labeling

Label is not available on this site.

12/21/1992 SUPPL-3 Labeling

Label is not available on this site.

10/05/1992 SUPPL-2 Labeling

Label is not available on this site.

05/20/1992 SUPPL-1 Labeling

Label is not available on this site.

ATENOLOL

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 072304 ALVOGEN MALTA
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 078512 AUROBINDO PHARMA
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 073543 DAVA PHARMS INC
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 077877 IPCA LABS LTD
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 073457 MYLAN
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 073026 SANDOZ
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 078210 SUN PHARM INDS INC
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 073476 SUN PHARM INDUSTRIES
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 074056 TEVA
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 077443 UNIQUE PHARM LABS
ATENOLOL ATENOLOL 100MG TABLET;ORAL Prescription No AB 076900 ZYDUS PHARMS USA
TENORMIN ATENOLOL 100MG TABLET;ORAL Prescription Yes AB 018240 ALVOGEN MALTA

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 073646 ALVOGEN MALTA
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 078512 AUROBINDO PHARMA
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 077877 IPCA LABS LTD
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 073457 MYLAN
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 074052 SANDOZ
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 078210 SUN PHARM INDS INC
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 074499 SUN PHARM INDUSTRIES
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 074056 TEVA
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 077443 UNIQUE PHARM LABS
ATENOLOL ATENOLOL 25MG TABLET;ORAL Prescription No AB 076900 ZYDUS PHARMS USA
TENORMIN ATENOLOL 25MG TABLET;ORAL Prescription Yes AB 018240 ALVOGEN MALTA

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 072303 ALVOGEN MALTA
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 078512 AUROBINDO PHARMA
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073542 DAVA PHARMS INC
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 077877 IPCA LABS LTD
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073457 MYLAN
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073025 SANDOZ
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 078210 SUN PHARM INDS INC
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 073475 SUN PHARM INDUSTRIES
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 074056 TEVA
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 077443 UNIQUE PHARM LABS
ATENOLOL ATENOLOL 50MG TABLET;ORAL Prescription No AB 076900 ZYDUS PHARMS USA
TENORMIN ATENOLOL 50MG TABLET;ORAL Prescription Yes AB 018240 ALVOGEN MALTA

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