Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074454
Company: G AND W LABS INC
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 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
09/25/1995 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
06/10/2015 SUPPL-30 Labeling

Label is not available on this site.

12/03/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/2001 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/16/2000 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/13/1999 SUPPL-6 Labeling

Label is not available on this site.

07/07/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/07/1999 SUPPL-4 Labeling

Label is not available on this site.

07/07/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/12/1999 SUPPL-2 Labeling

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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