Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212287
Company: ASTRAL

Products on ANDA 212287

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212287

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2022	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/18/2021	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/18/2021	SUPPL-4	Labeling-Package Insert		Label is not available on this site.