Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072637
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Prescription AB No No
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE 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
02/01/1989 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
12/11/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

06/12/1998 SUPPL-11 Labeling

Label is not available on this site.

12/05/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/25/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/09/1993 SUPPL-5 Labeling

Label is not available on this site.

11/05/1992 SUPPL-4 Labeling

Label is not available on this site.

02/04/1991 SUPPL-3 Labeling

Label is not available on this site.

08/29/1990 SUPPL-2 Labeling

Label is not available on this site.

03/22/1989 SUPPL-1 Labeling

Label is not available on this site.

ALBUTEROL SULFATE

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Prescription No AB 072894 MYLAN
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Prescription No AB 072637 SUN PHARM INDUSTRIES

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL Prescription No AB 072894 MYLAN
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL Prescription No AB 072637 SUN PHARM INDUSTRIES

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