Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073542
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
12/19/1991 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
09/19/2005 SUPPL-20 Labeling

Label is not available on this site.

05/21/2001 SUPPL-18 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/05/2000 SUPPL-15 Labeling

Label is not available on this site.

05/24/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/05/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/18/1997 SUPPL-11 Labeling

Label is not available on this site.

05/15/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/15/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/08/1994 SUPPL-8 Labeling

Label is not available on this site.

10/04/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/14/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/13/1993 SUPPL-5 Labeling

Label is not available on this site.

05/17/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/04/1993 SUPPL-3 Labeling

Label is not available on this site.

09/25/1992 SUPPL-2 Labeling

Label is not available on this site.

04/22/1992 SUPPL-1 Labeling

Label is not available on this site.

ATENOLOL

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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