U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212197
Company: QUAGEN
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
09/06/2019 ORIG-1 Approval STANDARD

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 078105 CHARTWELL MOLECULAR
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP;ORAL Prescription No AA 077788 CHARTWELL RX
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP;ORAL Prescription No AA 074454 COSETTE
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP;ORAL Prescription No AA 212197 QUAGEN
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP;ORAL Prescription No AA 073419 TEVA
Back to Top