Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073646
Company: ALVOGEN MALTA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATENOLOL ATENOLOL 25MG 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
07/31/1992 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
06/07/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

12/26/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

08/02/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/01/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/29/1997 SUPPL-6 Labeling

Label is not available on this site.

10/09/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/25/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/18/1994 SUPPL-3 Labeling

Label is not available on this site.

12/16/1993 SUPPL-2 Labeling

Label is not available on this site.

03/10/1993 SUPPL-1 Labeling

Label is not available on this site.

ATENOLOL

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

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