Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072894
Company: MYLAN
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 Yes
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
01/17/1991 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
07/16/1998 SUPPL-7 Labeling

Label is not available on this site.

02/05/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/29/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/18/1993 SUPPL-3 Labeling

Label is not available on this site.

11/05/1992 SUPPL-2 Labeling

Label is not available on this site.

09/23/1992 SUPPL-1 Manufacturing (CMC)

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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