Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091554
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/19/2011 | 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 |
---|---|---|---|---|---|
04/07/2021 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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04/07/2021 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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08/19/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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08/19/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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08/19/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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11/07/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
VANCOMYCIN HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 10GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205779 | EUGIA PHARMA |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062663 | FRESENIUS KABI USA |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205694 | GLAND PHARMA LTD |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215821 | HAINAN POLY |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204360 | HIKMA |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 063076 | HOSPIRA |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065455 | HOSPIRA INC |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215196 | MEITHEAL |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091554 | MYLAN LABS LTD |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200837 | SAGENT PHARMS |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 201048 | SANDOZ INC |
VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204125 | XELLIA PHARMS APS |