Application 019813
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DURAGESIC-100 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 100MCG/HR | Yes | No |
| 002 | DURAGESIC-75 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 75MCG/HR | Yes | No |
| 003 | DURAGESIC-50 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 50MCG/HR | Yes | No |
| 004 | DURAGESIC-25 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 25MCG/HR | Yes | Yes |
| 005 | DURAGESIC-12 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 12.5MCG/HR | Yes | No |
| 006 | DURAGESIC-37 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 37.5MCG/HR | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019813-001 | DURAGESIC-100 | FENTANYL | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | |
| N019813-002 | DURAGESIC-75 | FENTANYL | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | |
| N019813-003 | DURAGESIC-50 | FENTANYL | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | |
| N019813-004 | DURAGESIC-25 | FENTANYL | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | |
| N019813-005 | DURAGESIC-12 | FENTANYL | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | |
| N019813-006 | DURAGESIC-37 | FENTANYL | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-09-15 20:21 UTC | 2019-09 | N019813-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N019813-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N019813-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N019813-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N019813-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N019813-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N019813-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N019813-006 | AB | 1 | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FENTANYL | FENTANYL | Aveva Drug Delivery Systems Inc. | 73897c38-e4ec-40bc-9f41-3359ee23a5a8 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | FENTANYL |
| FENTANYL | FENTANYL | INGENUS PHARMACEUTICALS, LLC | bf02ffd0-cc5d-446b-b648-378f6885052f | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | FENTANYL |
| Fentanyl system | FENTANYL | ALVOGEN | 242759ef-cb6d-4e3e-9f8d-5e31efa1f289 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | FENTANYL |
| FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | 2a2238e9-4b5d-c56d-8663-dd354ff9ae0c | 2025-12-15 | Boxed warning, Warnings, Adverse reactions | FENTANYL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-7240 | Fentanyl | Fentanyl | Sandoz,Inc. | NDA | Current |
| 0781-7241 | Fentanyl | Fentanyl | Sandoz,Inc. | NDA | Current |
| 0781-7242 | Fentanyl | Fentanyl | Sandoz,Inc. | NDA | Current |
| 0781-7243 | Fentanyl | Fentanyl | Sandoz,Inc. | NDA | Current |
| 0781-7244 | Fentanyl | Fentanyl | Sandoz,Inc. | NDA | Current |
| 50458-090 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-090 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, | NDA | Current |
| 50458-090 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-091 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, | NDA | Current |
| 50458-091 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-092 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-092 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, | NDA | Current |
| 50458-092 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-093 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-093 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, | NDA | Current |
| 50458-093 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-094 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-094 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, | NDA | Current |
| 50458-094 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-101 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-101 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-101 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-101 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-101 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-101 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-102 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-102 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-102 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-102 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-102 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-102 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-104 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-104 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-104 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-104 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-104 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-104 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-105 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-105 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-105 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-105 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-105 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-105 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-106 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-106 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-106 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-106 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-106 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-106 | DURAGESIC | fentanyl | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 63629-4765 | Fentanyl | Fentanyl | Bryant Ranch Prepack | NDA | Current |
| 68258-3040 | Fentanyl | Fentanyl | Dispensing Solutions, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66520 | SUPPL | 2021-03-05 |
| 66519 | SUPPL | 2021-03-05 |
| 66509 | SUPPL | 2021-03-05 |
| 60341 | SUPPL | 2019-10-08 |
| 60325 | SUPPL | 2019-10-08 |
| 60324 | SUPPL | 2019-10-08 |
| 55843 | SUPPL | 2018-10-05 |
| 55842 | SUPPL | 2018-10-05 |
| 55655 | SUPPL | 2018-09-28 |
| 55654 | SUPPL | 2018-09-28 |
| 51915 | SUPPL | 2018-01-26 |
| 51914 | SUPPL | 2018-01-26 |
| 48570 | SUPPL | 2017-05-30 |
| 47185 | SUPPL | 2017-02-13 |
| 47097 | SUPPL | 2017-02-03 |
| 46394 | SUPPL | 2016-12-21 |
| 46237 | SUPPL | 2016-12-20 |
| 45460 | SUPPL | 2016-10-04 |
| 19254 | SUPPL | 2016-04-22 |
| 19253 | SUPPL | 2015-07-02 |
| 19252 | SUPPL | 2014-08-20 |
| 1642 | SUPPL | 2014-04-17 |
| 33979 | SUPPL | 2014-04-16 |
| 19251 | SUPPL | 2013-10-09 |
| 11735 | SUPPL | 2013-09-24 |
| 19250 | SUPPL | 2013-04-16 |
| 20375 | SUPPL | 2012-10-12 |
| 20374 | SUPPL | 2012-09-17 |
| 33978 | SUPPL | 2012-07-12 |
| 23965 | ORIG | 2012-07-11 |
| 19249 | SUPPL | 2012-07-11 |
| 19248 | SUPPL | 2012-07-11 |
| 33977 | SUPPL | 2010-04-01 |
| 41042 | SUPPL | 2009-01-12 |
| 41041 | SUPPL | 2009-01-12 |
| 41040 | SUPPL | 2009-01-12 |
| 20373 | SUPPL | 2009-01-12 |
| 20372 | SUPPL | 2009-01-12 |
| 20371 | SUPPL | 2009-01-12 |
| 20368 | ORIG | 2008-02-19 |
| 33974 | SUPPL | 2008-02-14 |
| 1639 | SUPPL | 2008-02-14 |
| 41039 | SUPPL | 2007-07-09 |
| 41038 | SUPPL | 2007-07-09 |
| 20370 | SUPPL | 2007-07-09 |
| 20369 | SUPPL | 2007-07-09 |
| 23557 | ORIG | 2005-07-29 |
| 33976 | SUPPL | 2005-02-08 |
| 1641 | SUPPL | 2005-02-08 |
| 33975 | SUPPL | 2003-06-08 |
| 1640 | SUPPL | 2003-06-08 |
| 19247 | SUPPL | 2001-04-11 |
| 1638 | SUPPL | 2001-04-11 |
| 51855 | ORIG | 1900-01-01 |
| 51854 | ORIG | 1900-01-01 |
| 51853 | ORIG | 1900-01-01 |
| 51852 | ORIG | 1900-01-01 |
| 51851 | ORIG | 1900-01-01 |