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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062772
Company: HQ SPECLT PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None 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
04/15/1993 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
02/15/2018 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

05/31/2013 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

07/23/2007 SUPPL-6 Labeling

Label is not available on this site.

02/28/2007 SUPPL-4 Labeling

Label is not available on this site.

11/05/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/14/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

AMPICILLIN SODIUM

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090354 ANTIBIOTICE
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065499 EUGIA PHARMA SPECLTS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062772 HQ SPECLT PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062719 ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201025 MYLAN LABS LTD
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090583 SAGENT PHARMS INC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 061395 SANDOZ

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090354 ANTIBIOTICE
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065499 EUGIA PHARMA SPECLTS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062772 HQ SPECLT PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062797 ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201025 MYLAN LABS LTD
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090583 SAGENT PHARMS INC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 061395 SANDOZ

INJECTABLE;INJECTION; EQ 250MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090354 ANTIBIOTICE
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065499 EUGIA PHARMA SPECLTS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062772 HQ SPECLT PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062719 ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090583 SAGENT PHARMS INC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 061395 SANDOZ

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090354 ANTIBIOTICE
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065499 EUGIA PHARMA SPECLTS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062772 HQ SPECLT PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062719 ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090583 SAGENT PHARMS INC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 061395 SANDOZ
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