Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074749
Company: HI TECH PHARMA
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
01/30/1998 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
09/25/2017 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/21/2001 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/21/2001 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/21/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/2001 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/16/2001 SUPPL-5 Labeling

Label is not available on this site.

11/04/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/04/1999 SUPPL-3 Labeling

Label is not available on this site.

11/04/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/04/1999 SUPPL-1 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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