Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090577
Company: ACS DOBFAR
Company: ACS DOBFAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IMIPENEM AND CILASTATIN | CILASTATIN SODIUM; IMIPENEM | EQ 250MG BASE/VIAL;250MG/VIAL | POWDER;INTRAVENOUS | Prescription | None | No | Yes |
IMIPENEM AND CILASTATIN | CILASTATIN SODIUM; IMIPENEM | EQ 500MG BASE/VIAL;500MG/VIAL | POWDER;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
12/21/2011 | 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 |
---|---|---|---|---|---|
02/05/2024 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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07/09/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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07/09/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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05/29/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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05/29/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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04/15/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
IMIPENEM AND CILASTATIN
POWDER;INTRAVENOUS; EQ 500MG BASE/VIAL;500MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IMIPENEM AND CILASTATIN | CILASTATIN SODIUM; IMIPENEM | EQ 500MG BASE/VIAL;500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 090577 | ACS DOBFAR |
IMIPENEM AND CILASTATIN | CILASTATIN SODIUM; IMIPENEM | EQ 500MG BASE/VIAL;500MG/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207594 | HQ SPCLT PHARMA |
PRIMAXIN | CILASTATIN SODIUM; IMIPENEM | EQ 500MG BASE/VIAL;500MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 050587 | MERCK |