Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 076507
Company: TARO
Company: TARO
| 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/2004/76507ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/19/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/19/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/19/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/18/2012 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/16/2011 | SUPPL-3 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 11/06/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/09/2008 | SUPPL-1 | Manufacturing (CMC)-Control |
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 | 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 GENERICS |
| FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 078423 | HARRIS PHARM |
| FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 076077 | IVAX SUB TEVA PHARMS |
| FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 076351 | MYLAN |
| FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
| FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 074681 | TEVA |
| FLUCONAZOLE | FLUCONAZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 076957 | UNIQUE PHARM LABS |
| 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 | 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 GENERICS |
| FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 078423 | HARRIS PHARM |
| FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 076077 | IVAX SUB TEVA PHARMS |
| FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 076351 | MYLAN |
| FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
| FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 074681 | TEVA |
| FLUCONAZOLE | FLUCONAZOLE | 100MG | TABLET;ORAL | Prescription | No | AB | 076957 | UNIQUE PHARM LABS |
| 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 | 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 GENERICS |
| FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 078423 | HARRIS PHARM |
| FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 076077 | IVAX SUB TEVA PHARMS |
| FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 076351 | MYLAN |
| FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
| FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 074681 | TEVA |
| FLUCONAZOLE | FLUCONAZOLE | 150MG | TABLET;ORAL | Prescription | No | AB | 076957 | UNIQUE PHARM LABS |
| 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 | 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 GENERICS |
| FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 078423 | HARRIS PHARM |
| FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 076077 | IVAX SUB TEVA PHARMS |
| FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 076351 | MYLAN |
| FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 076507 | TARO |
| FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 074681 | TEVA |
| FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 076957 | UNIQUE PHARM LABS |
| FLUCONAZOLE | FLUCONAZOLE | 200MG | TABLET;ORAL | Prescription | No | AB | 208963 | ZYDUS PHARMS |
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