Application 211404
- Type
- ANDA
- Sponsor
- PLD ACQUISITIONS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | TABLET;ORAL | 38MG;200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET / ORAL | 2024-04-11 |
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 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | 8072bd15b7f6… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211404-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 38MG;200MG | TABLET / ORAL | 2024-04-11 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Ibuprofen PM | DIPHENHYDRAMINE CITRATE, IBUPROFEN | Safeway, Inc. | e49d1e9e-99a6-4d81-90d6-ef23a584a3d1 | 2026-01-05 | Warnings | 211404 ANDA211404 |
| Ibuprofen PM | DIPHENHYDRAMINE CITRATE, IBUPROFEN | Family Dollar (FAMILY WELLNESS) | e01be0d7-e16d-44f1-9a0c-251ff9a65d28 | 2025-10-22 | Warnings | 211404 ANDA211404 |
| Ibuprofen PM | DIPHENHYDRAMINE CITRATE, IBUPROFEN | WR Group, Inc. | 1e2feaf0-7fff-43d5-bcfe-9f2851bdc805 | 2025-03-25 | Warnings | 211404 ANDA211404 |
| Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg | IBUPROFEN, DIPHENHYDRAMINE CITRATE | PLD Acquisitions LLC DBA Avma Pharma Solutions | a7d729bf-6d7a-415a-a414-cae0ba6d0063 | 2024-04-24 | Warnings | 211404 ANDA211404 |
| Ibuprofen PM | DIPHENHYDRAMINE CITRATE, IBUPROFEN | WALMART INC. (see also Equate) | d86151b6-d5c5-4d93-9cfd-43ab7ad0443a | 2024-04-15 | Warnings | 211404 ANDA211404 |