Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073419
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/30/1992 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
08/30/2001 SUPPL-26 Manufacturing (CMC)-Facility

Label is not available on this site.

07/27/2000 SUPPL-25 Labeling

Label is not available on this site.

07/07/2000 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

05/06/1998 SUPPL-23 Labeling

Label is not available on this site.

05/27/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/27/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/07/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/08/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/12/1995 SUPPL-17 Labeling

Label is not available on this site.

05/04/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/22/1995 SUPPL-14 Labeling

Label is not available on this site.

02/02/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/22/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/02/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/08/1994 SUPPL-10 Labeling

Label is not available on this site.

12/03/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/09/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/28/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/30/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

ALBUTEROL SULFATE

SYRUP;ORAL; EQ 2MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP;ORAL Prescription No AA 079241 AMNEAL PHARMS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP;ORAL Prescription No AA 074454 G AND W LABS INC
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP;ORAL Prescription No AA 074749 HI TECH PHARMA
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP;ORAL Prescription No AA 073419 TEVA
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP;ORAL Prescription No AA 078105 VINTAGE
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP;ORAL Prescription No AA 077788 VISTAPHARM

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