Application 080845
- Type
- ANDA
- Sponsor
- FOSUN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 50MG | No | No |
| 002 | DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | CAPSULE;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | ||
| A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / 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 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG | CAPSULE / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080845-002 | DIPHENHYDRAMINE HYDROCHLORIDE | 25MG | CAPSULE / ORAL | Approved before 1982 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | a4d6ecb9-ea67-41ed-917b-9bb4d1e50551 | 2024-10-17 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 08fda81a-bedd-4ff3-9c32-2066d2cea3f9 | 2024-10-17 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FSA STORE INC. | ec6aef90-ece1-4fe6-e053-2995a90a9310 | 2024-10-16 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Discount Drug Mart | 4f42c8d2-0538-4bcd-aac0-e26103a30499 | 2024-10-16 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 8256c1fb-683d-56ab-e053-2a91aa0ac197 | 2024-10-15 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 9f95715f-63dc-6086-e053-2a95a90adb0c | 2024-10-15 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Diphenhydramine | DIPHENHYDRAMINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | 921b9f64-1096-46db-866a-67f0f9ff6790 | 2024-10-14 | Warnings, Adverse reactions | DIPHENHYDRAMINE HYDROCHLORIDE |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 8eab9d79-69c1-44b8-9145-a7ebd887d54d | 2024-10-11 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | e4963eec-fb4a-425c-be19-f514b4f10a7f | 2024-10-11 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 5fab9bd4-66d7-4356-a778-8900b2e270e2 | 2024-10-11 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | KinderFarms, LLC | 57a130db-2b27-4e09-b0bb-179d4ef52c15 | 2024-10-04 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Sominex | DIPHENHYDRAMINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | f70ce1a6-c334-025e-e053-6294a90ae53f | 2024-10-03 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Benadryl Ultratabs | DIPHENHYDRAMINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 76433e3c-142c-4704-8b2b-d602f008c377 | 2024-10-02 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| meijer NIGHTTIME Sleep Aid CAPLET | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 1c2b57b3-92cb-256b-e063-6394a90ad41b | 2024-09-09 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Benadryl Allergy EXTRA STRENGTH | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | dd0a8069-18d8-5696-e053-2995a90a2f22 | 2024-09-06 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 5a2053d4-9c0d-4613-9cf5-0067173f3730 | 2024-08-16 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Up and Up Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Target Corporation | 0ab5a374-d565-4385-bee3-538a8f09b19e | 2024-08-15 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 8d985ad7-71b9-493f-9b9a-d6ef280f72dd | 2024-08-12 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 445e49a2-6ed0-434c-aaea-3ce14bc7df59 | 2024-08-12 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
| Rest Simply | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 3618eb73-6929-4ca5-833d-265b006f15f9 | 2024-08-12 | Warnings | DIPHENHYDRAMINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.