Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078105
Company: VINTAGE
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
12/27/2006 ORIG-1 Approval

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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