Application 077775
- Type
- ANDA
- Sponsor
- NOVEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENTANYL-25 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 25MCG/HR | No | No |
| 002 | FENTANYL-50 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 50MCG/HR | No | No |
| 003 | FENTANYL-75 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 75MCG/HR | No | No |
| 004 | FENTANYL-100 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 100MCG/HR | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077775-001 | FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | ||
| A077775-002 | FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | ||
| A077775-003 | FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | ||
| A077775-004 | FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A077775-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077775-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077775-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077775-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077775-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077775-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077775-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077775-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077775-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077775-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077775-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077775-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077775-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077775-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077775-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077775-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077775-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077775-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077775-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077775-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077775-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077775-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077775-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077775-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077775-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077775-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077775-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077775-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077775-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077775-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077775-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077775-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077775-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077775-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077775-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077775-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077775-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077775-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077775-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077775-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2009-10-16 | 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#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44537 | ORIG | 2015-03-24 |