Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205883
Company: AMNEAL PHARMS
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
04/12/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205883Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205883Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2019 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

07/21/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

07/21/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

07/21/2019 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/21/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/12/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205883Orig1s000lbl.pdf

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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