Application 077062
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
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 |
|---|---|---|---|---|---|---|---|
| A077062-001 | FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | ||
| A077062-002 | FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | ||
| A077062-003 | FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | ||
| A077062-004 | FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 |
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 | A077062-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077062-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077062-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077062-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077062-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077062-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077062-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077062-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077062-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077062-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077062-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077062-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077062-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077062-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077062-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077062-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077062-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077062-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077062-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077062-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077062-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077062-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077062-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077062-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077062-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077062-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077062-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077062-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077062-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077062-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077062-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077062-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077062-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077062-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077062-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077062-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077062-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077062-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077062-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077062-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A077062-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077062-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077062-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077062-004 | AB | 1 | 74a2ff9319b5… |
| 2019-09-15 20:21 UTC | 2019-09 | A077062-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077062-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077062-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077062-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077062-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077062-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077062-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077062-004 | 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 |
|---|---|---|---|---|---|
| 49884-761 | Fentanyl | Fentanyl | Par Pharmaceutical Inc. | ANDA | Current |
| 49884-762 | Fentanyl | Fentanyl | Par Pharmaceutical Inc. | ANDA | Current |
| 49884-763 | Fentanyl | Fentanyl | Par Pharmaceutical Inc. | ANDA | Current |
| 49884-764 | Fentanyl | Fentanyl | Par Pharmaceutical Inc. | ANDA | Current |
| 51862-314 | Fentanyl | Fentanyl | Mayne Pharma | ANDA | Current |
| 51862-315 | Fentanyl | Fentanyl | Mayne Pharma | ANDA | Current |
| 51862-316 | Fentanyl | Fentanyl | Mayne Pharma | ANDA | Current |
| 51862-317 | Fentanyl | Fentanyl | Mayne Pharma | ANDA | Current |
| 60760-911 | Fentanyl | FENTANYL | St. Marys Medical Park Ph | ANDA | Current |
| 60760-912 | Fentanyl | FENTANYL | St. Marys Medical Park Pharmacy | ANDA | Current |
| 71335-0556 | Fentanyl | Fentanyl | Bryant Ranch Prepack | ANDA | Current |
| 71335-0604 | Fentanyl | Fentanyl | Bryant Ranch Prepack | ANDA | Current |
| 71335-0649 | Fentanyl | Fentanyl | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44532 | ORIG | 2015-06-16 |