Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205835
Company: EUGIA PHARMA
Company: EUGIA PHARMA
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 |
---|---|---|---|---|---|---|---|
03/27/2017 | 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 |
---|---|---|---|---|---|
08/30/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
08/30/2019 | SUPPL-2 | 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 | 216154 | BROOKS STERISCIENCE |
MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205835 | EUGIA PHARMA |
MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206141 | GLAND |
MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210773 | HQ SPCLT PHARMA |
MEROPENEM | MEROPENEM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216424 | QILU |
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 | 216154 | BROOKS STERISCIENCE |
MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205835 | EUGIA PHARMA |
MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206141 | GLAND |
MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210773 | HQ SPCLT PHARMA |
MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216424 | QILU |
MEROPENEM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206086 | SAVIOR LIFETEC CORP |
MERREM | MEROPENEM | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050706 | PFIZER |