Diflorasone Topical Ointment
- Brand(s)
- Apexicon
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Taro Pharmaceuticals U.S.A., Inc. (2015-06-26)
- Oldest Current Product
- 1999-04-27
- License(s)
- ANDA
- RxNORM
- TOPICAL OINTMENT\DIFLORASONE
- FDAOB
- TOPICAL\OINTMENT\DIFLORASONE DIACETATE
- SPL Active
- TOPICAL\OINTMENT\DIFLORASONE DIACETATE
- SPL Moiety
- TOPICAL\OINTMENT\DIFLORASONE
TOPICAL\OINTMENT\DIFLORASONE DIACETATE
product(s) by strength(s)
diflorasone diacetate 0.0005 mg/mg topical ointment
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001680243 | ANDA | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. | 1999-04-27 | DIFLORASONE DIACETATE | TOPICAL | OINTMENT | ANDA075374 | 5b92dbac-3f28-4c72-b529-7455e1b7b366 | |
| 2 | 004620394 | Apexicon | ANDA | Pharmaderm, A Division Of Nycomed Us Inc. | 2009-09-30 | DIFLORASONE DIACETATE | TOPICAL | OINTMENT | ANDA075374 | a44f7c47-1fe7-4f5a-8bef-6df192c3357c |
| 3 | 516721295 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 1999-05-14 | DIFLORASONE DIACETATE | TOPICAL | OINTMENT | ANDA075331 | b304dfca-e840-4c03-8217-73aaa5360277 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA075331 | DIFLORASONE DIACETATE | TARO PHARMACEUTICALS INC | 1999-05-14 | ANDA075331_001 | |
| 2 | ANDA075374 | DIFLORASONE DIACETATE | FOUGERA PHARMACEUTICALS INC | 1999-04-27 | ANDA075374_001 | |
| 3 | ANDA206572 | DIFLORASONE DIACETATE | VERSAPHARM INC | 2015-07-24 | ANDA206572_001 | |
| 4 | NDA017994 | PSORCON E | True | PHARMACIA AND UPJOHN CO | NDA017994_001 | |
| 5 | NDA019260 | PSORCON | True | PHARMACIA AND UPJOHN CO | 1985-08-28 | NDA019260_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA075331_001 | RX | DIFLORASONE DIACETATE (0.05%) | TOPICAL | OINTMENT | True | AB | 1999-05-14 | DIFLORASONE DIACETATE |
| 2 | ANDA075374_001 | RX | DIFLORASONE DIACETATE (0.05%) | TOPICAL | OINTMENT | False | AB | 1999-04-27 | DIFLORASONE DIACETATE |
| 3 | ANDA206572_001 | RX | DIFLORASONE DIACETATE (0.05%) | TOPICAL | OINTMENT | False | AB | 2015-07-24 | DIFLORASONE DIACETATE |
| 4 | NDA017994_001 | discontinued | DIFLORASONE DIACETATE (0.05%) | TOPICAL | OINTMENT | False | PSORCON E | ||
| 5 | NDA019260_001 | discontinued | DIFLORASONE DIACETATE (0.05%) | TOPICAL | OINTMENT | False | 1985-08-28 | PSORCON |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 5b92dbac-3f28-4c72-b529-7455e1b7b366 (view SPL) | DIFLORASONE DIACETATE OINTMENT USP, 0.05% | prescription | Human Prescription | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. | 2014-08-12 | 6 | 001680243 | |
| 2 | a44f7c47-1fe7-4f5a-8bef-6df192c3357c (view SPL) | ApexiCon Ointment(diflorasone diacetate ointment, USP, 0.05%) | prescription | Human Prescription | Pharmaderm, A Division Of Nycomed Us Inc. | ANALYSIS, MANUFACTURE | 2009-09-30 | 2 | 004620394 |
| 3 | b304dfca-e840-4c03-8217-73aaa5360277 (view SPL) | Diflorasone Diacetate Ointment USP, 0.05% | prescription | Human Prescription | Taro Pharmaceuticals U.S.A., Inc. | MANUFACTURE | 2015-06-26 | 3 | 516721295 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII