Drugs@FDA: FDA-Approved Drugs
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | AB | No | No |
FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
01/25/2006 | 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 |
---|---|---|---|---|---|
10/24/2023 | SUPPL-25 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
07/20/2023 | SUPPL-24 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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07/20/2023 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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07/06/2022 | SUPPL-21 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
07/06/2022 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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10/06/2021 | SUPPL-18 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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06/28/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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06/28/2019 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
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06/28/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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03/14/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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03/14/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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03/14/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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12/16/2011 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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10/13/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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08/28/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
FLUCONAZOLE
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIFLUCAN | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 019949 | PFIZER |
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 078423 | ANI PHARMS |
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 077731 | AUROBINDO PHARMA |
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 076665 | CHARTWELL |
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 076658 | DR REDDYS LABS INC |
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 077253 | GLENMARK PHARMS LTD |
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 076957 | THINQ PHARM-CRO PVT |
FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 208963 | ZYDUS PHARMS |
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIFLUCAN | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 019949 | PFIZER |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 078423 | ANI PHARMS |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 077731 | AUROBINDO PHARMA |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 076665 | CHARTWELL |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 076658 | DR REDDYS LABS INC |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 077253 | GLENMARK PHARMS LTD |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 076957 | THINQ PHARM-CRO PVT |
FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 208963 | ZYDUS PHARMS |
TABLET;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIFLUCAN | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 019949 | PFIZER |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 078423 | ANI PHARMS |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 077731 | AUROBINDO PHARMA |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 076665 | CHARTWELL |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 076658 | DR REDDYS LABS INC |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 077253 | GLENMARK PHARMS LTD |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 076957 | THINQ PHARM-CRO PVT |
FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 208963 | ZYDUS PHARMS |
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIFLUCAN | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | Yes | AB | 019949 | PFIZER |
FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 078423 | ANI PHARMS |
FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 077731 | AUROBINDO PHARMA |
FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 076665 | CHARTWELL |
FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 076658 | DR REDDYS LABS INC |
FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 077253 | GLENMARK PHARMS LTD |
FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 076957 | THINQ PHARM-CRO PVT |
FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 208963 | ZYDUS PHARMS |