Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091404
Company: ACS DOBFAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription AP No No
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription AP 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
10/26/2011 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
07/21/2019 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

07/21/2019 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

07/21/2019 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

07/21/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/21/2019 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/22/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

07/22/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

07/22/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

11/10/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/22/2015 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

MEROPENEM

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 091404 ACS DOBFAR
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 204139 ACS DOBFAR SPA
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 205883 AMNEAL PHARMS
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 205835 AUROBINDO PHARMA LTD
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 204854 DAEWOONG PHARM CO
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 206141 GLAND PHARMA LTD
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 090940 HOSPIRA INC
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 210773 HQ SPCLT PHARMA
MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 206086 SAVIOR LIFETEC CORP
MERREM MEROPENEM 500MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 050706 PFIZER

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 091404 ACS DOBFAR
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 204139 ACS DOBFAR SPA
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 205883 AMNEAL PHARMS
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 205835 AUROBINDO PHARMA LTD
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 204854 DAEWOONG PHARM CO
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 206141 GLAND PHARMA LTD
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 090940 HOSPIRA INC
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 210773 HQ SPCLT PHARMA
MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 206086 SAVIOR LIFETEC CORP
MERREM MEROPENEM 1GM/VIAL INJECTABLE;INJECTION Prescription Yes AP 050706 PFIZER

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