Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076665
Company: CHARTWELL
Company: CHARTWELL
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 |
---|---|---|---|---|---|---|---|
07/29/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76665ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/22/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
06/22/2020 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
06/22/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
03/14/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
03/14/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
03/14/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
05/27/2005 | SUPPL-1 | 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 |