Application 050337
- Type
- NDA
- Sponsor
- APOTHECON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | DYNAPEN | DICLOXACILLIN SODIUM | FOR SUSPENSION;ORAL | EQ 62.5MG BASE/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050337-002 | DYNAPEN | DICLOXACILLIN SODIUM | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N050337-002 | DYNAPEN | EQ 62.5MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| DICLOXACILLIN SODIUM | DICLOXACILLIN SODIUM | Redpharm Drug | 58e6ee7a-8237-ec66-e063-6394a90a5cae | 2026-08-13 | Warnings, Adverse reactions | DICLOXACILLIN SODIUM |
| DICLOXACILLIN SODIUM | DICLOXACILLIN SODIUM | Chartwell RX, LLC | 270c0839-c30c-475d-a505-e70855652c9e | 2026-07-23 | Warnings, Adverse reactions | DICLOXACILLIN SODIUM |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | PD-Rx Pharmaceuticals, Inc. | c17cd62d-ff5d-47ba-8673-3346c7f2365f | 2026-05-21 | Warnings, Adverse reactions | DICLOXACILLIN SODIUM |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | PD-Rx Pharmaceuticals, Inc. | 9e2bbe03-44cb-45d1-acdb-b61d9016055e | 2025-10-20 | Warnings, Adverse reactions | DICLOXACILLIN SODIUM |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | PD-Rx Pharmaceuticals, Inc. | 24e821aa-85b8-4f5a-aa13-83ff132952ca | 2025-10-15 | Warnings, Adverse reactions | DICLOXACILLIN SODIUM |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | Bryant Ranch Prepack | 3e4842ec-773b-4aeb-b37d-1c4e3cf53424 | 2024-01-18 | Warnings, Adverse reactions | DICLOXACILLIN SODIUM |
| DICLOXACILLIN SODIUM | DICLOXACILLIN SODIUM | Aurobindo Pharma Limited | 9074b5a6-850c-4144-9097-bb21073ee54d | 2023-12-27 | Warnings, Adverse reactions | DICLOXACILLIN SODIUM |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | Teva Pharmaceuticals USA, Inc. | 8478f242-c715-4984-ac1d-dc79dc28665e | 2022-06-22 | Warnings, Adverse reactions | DICLOXACILLIN SODIUM |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | Asclemed USA, Inc. | a4174fda-68f7-4834-be58-dd6b167cf9f0 | 2020-11-14 | Warnings, Adverse reactions | DICLOXACILLIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.