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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201406
Company: ANTIBIOTICE

Products on ANDA 201406

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201406

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/2015	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201406Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/27/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/27/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201406

AMPICILLIN AND SULBACTAM

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065406	ACS DOBFAR
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201406	ANTIBIOTICE
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090349	EUGIA PHARMA SPECLTS
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065176	HQ SPECLT PHARMA
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065222	ISTITUTO BIO ITA SPA
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201024	ONESOURCE SPECIALTY
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065241	SANDOZ
UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050608	PFIZER

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065406	ACS DOBFAR
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201406	ANTIBIOTICE
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090349	EUGIA PHARMA SPECLTS
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065176	HQ SPECLT PHARMA
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065222	ISTITUTO BIO ITA SPA
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201024	ONESOURCE SPECIALTY
AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065241	SANDOZ
UNASYN	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050608	PFIZER

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