Drugs@FDA: FDA-Approved Drugs
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DANAZOL | DANAZOL | 200MG | CAPSULE;ORAL | Prescription | AB | No | Yes |
DANAZOL | DANAZOL | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
DANAZOL | DANAZOL | 50MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
08/09/1996 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/074582_danazol_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/22/2018 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
03/19/2012 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
03/28/2001 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/21/1999 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
05/20/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/26/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/26/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/26/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/01/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/29/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
05/29/1998 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
DANAZOL
CAPSULE;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DANAZOL | DANAZOL | 200MG | CAPSULE;ORAL | Prescription | No | AB | 074582 | BARR |
DANAZOL | DANAZOL | 200MG | CAPSULE;ORAL | Prescription | No | AB | 077246 | LANNETT CO INC |
CAPSULE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DANAZOL | DANAZOL | 100MG | CAPSULE;ORAL | Prescription | No | AB | 074582 | BARR |
DANAZOL | DANAZOL | 100MG | CAPSULE;ORAL | Prescription | No | AB | 078214 | LANNETT |
DANAZOL | DANAZOL | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077246 | LANNETT CO INC |
CAPSULE;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DANAZOL | DANAZOL | 50MG | CAPSULE;ORAL | Prescription | No | AB | 074582 | BARR |
DANAZOL | DANAZOL | 50MG | CAPSULE;ORAL | Prescription | No | AB | 078214 | LANNETT |
DANAZOL | DANAZOL | 50MG | CAPSULE;ORAL | Prescription | No | AB | 077246 | LANNETT CO INC |