Application 012157
- Type
- NDA
- Sponsor
- MEDICIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORFLEX | ORPHENADRINE CITRATE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012157-001 | NORFLEX | ORPHENADRINE CITRATE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N012157-001 | NORFLEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N012157-001 | NORFLEX | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, Approved before 1982 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Orphenadrine Citrate | ORPHENADRINE CITRATE | St. Mary's Medical Park Pharmacy | 59000b66-166e-75d2-e053-2a91aa0af3c0 | 2026-06-26 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | REMEDYREPACK INC. | 7905e80f-b60b-48e8-8e63-a3e50211bfe4 | 2026-04-28 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | Bryant Ranch Prepack | 1b4e379e-8051-421f-a0f4-ad9e6fb9476a | 2026-02-26 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | A-S Medication Solutions | 80ef7fb4-7c50-4d25-915e-f9d4a2ccd199 | 2026-01-20 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | PD-Rx Pharmaceuticals, Inc. | 87d78229-f022-4b42-a03c-4e6a985c714f | 2026-01-07 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | Northwind Health Company, LLC | 106be130-b4f8-5ca1-e063-6294a90a1590 | 2026-01-01 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | Lupin Pharmaceuticals, Inc. | 7b76c8a7-dd0c-481c-8299-26dfd38ce066 | 2025-09-10 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Preferred Pharmaceuticals, Inc. | 8ca9438d-320f-4499-aee7-6b8ca7cccc65 | 2025-09-04 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate ER | ORPHENADRINE CITRATE | Advanced Rx Pharmacy of Tennessee, LLC | b5a6846a-ebb3-1fdd-e053-2a95a90a4130 | 2024-12-31 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | Advanced Rx Pharmacy of Tennessee, LLC | fc63d413-39bd-409d-e053-6294a90a1463 | 2024-12-31 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Lake Erie Medical DBA Quality Care Products LLC | 233915f1-7d58-4b4c-a2bb-e73179d61d07 | 2024-12-16 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Bryant Ranch Prepack | 8408d24e-3948-548d-bb12-b1edf0c05e12 | 2024-08-27 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | NuCare Pharmaceuticals, Inc. | 3eb1b1cc-ed7a-6f0f-e054-00144ff88e88 | 2024-08-13 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine citrate | ORPHENADRINE CITRATE | Hikma Pharmaceuticals USA Inc. | ed406e8a-ec00-4711-ae2b-3c5af4f15438 | 2024-08-08 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | RedPharm Drug | 1cff761d-e594-a9e6-e063-6394a90a1fd5 | 2024-07-11 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Sandoz Inc | 239018ff-cec6-46de-ae9d-26c9ec034a32 | 2024-03-22 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Proficient Rx LP | cf620257-7497-44c1-9853-87f96d262fbd | 2023-12-01 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Sagent Pharmaceuticals | c8d8596a-b81f-4b83-a2f3-a55922ca4a82 | 2023-11-14 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Proficient Rx LP | 37e6a157-5d0d-4887-9a26-ed5521fb08e6 | 2019-11-01 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Actavis Pharma, Inc. | aec8ad3a-f717-4e74-b7b9-19debdaad79a | 2016-07-20 | Warnings, Adverse reactions | ORPHENADRINE CITRATE |