Application 019716
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIPROLENE | BETAMETHASONE DIPROPIONATE | LOTION, AUGMENTED;TOPICAL | EQ 0.05% BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019716-001 | DIPROLENE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019716-001 | DIPROLENE | EQ 0.05% BASE | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019716-001 | DIPROLENE | EQ 0.05% BASE | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019716-001 | DIPROLENE | EQ 0.05% BASE | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019716-001 | DIPROLENE | EQ 0.05% BASE | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019716-001 | DIPROLENE | EQ 0.05% BASE | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019716-001 | DIPROLENE | EQ 0.05% BASE | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019716-001 | DIPROLENE | EQ 0.05% BASE | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N019716-001 | DIPROLENE | EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION, AUGMENTED / TOPICAL | RLD | 1988-08-01 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Betamethasone Dipropionate | BETAMETHASONE DIPROPIONATE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0173ed23-9f7c-466e-9eba-f6859d05f987 | 2026-07-29 | Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone dipropionate | BETAMETHASONE DIPROPIONATE | Redpharm Drug | 5718b3bd-77b3-8034-e063-6294a90af5e0 | 2026-07-21 | Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone dipropionate | BETAMETHASONE DIPROPIONATE | A-S Medication Solutions | b5291e39-40a0-4362-9281-97f5fb4025d9 | 2026-05-11 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | Aurobindo Pharma Limited | a4f8db3a-0aed-451c-98ba-c4ce37656792 | 2026-05-04 | Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Sernivo | BETAMETHASONE DIPROPIONATE | Primus Pharmaceuticals, Inc. | b1b3d1b0-da9b-11eb-ad76-0800200c9a66 | 2026-04-22 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone Dipropionate | BETAMETHASONE DIPROPIONATE | Preferred Pharmaceuticals, Inc. | 5683885d-461c-4e7e-bbe8-dc231d706192 | 2026-03-19 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone Dipropionate | BETAMETHASONE DIPROPIONATE | Preferred Pharmaceuticals, Inc. | 54eff1fc-c611-4929-bb44-c1834c08f506 | 2026-03-19 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone Dipropionate | BETAMETHASONE DIPROPIONATE | A-S Medication Solutions | abd5a08c-4bb7-46c9-9e2e-0a89c43d46c8 | 2026-02-06 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone Dipropionate | BETAMETHASONE DIPROPIONATE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 4f411e41-00dc-47cf-8517-3ff5876e1bf5 | 2026-01-30 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone Dipropionate | BETAMETHASONE DIPROPIONATE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 853399f8-95a7-41f3-80e7-7ed8e3ff1a5e | 2026-01-30 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone Dipropionate | BETAMETHASONE DIPROPIONATE | Prasco Laboratories | f5b50c00-cc6f-4296-a9ae-b16888cef4dd | 2025-11-19 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| DIPROLENE | BETAMETHASONE DIPROPIONATE | Organon LLC | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 2025-11-19 | Warnings, Adverse reactions | DIPROLENE BETAMETHASONE DIPROPIONATE |
| Betamethasone dipropionate | BETAMETHASONE DIPROPIONATE | Lupin Pharmaceuticals, Inc. | 216d5b7f-4236-4882-b899-be17cb1a1584 | 2025-11-13 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone Dipropionate | BETAMETHASONE DIPROPIONATE | Encube Ethicals, Inc. | 7e946599-2fb4-4426-bb59-fbb71d89dac8 | 2025-11-11 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | Bryant Ranch Prepack | 1d40b962-5d97-4416-b46d-b0785acd261d | 2025-10-21 | Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone Dipropionate | BETAMETHASONE DIPROPIONATE | REMEDYREPACK INC. | 7cacf0ec-3db9-48be-9a76-93ed4a1f042c | 2025-09-29 | Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone Dipropionate | BETAMETHASONE DIPROPIONATE | Sun Pharmaceutical Industries, Inc. | 000ae256-a337-4903-845b-003777a4efa8 | 2025-09-26 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | Bryant Ranch Prepack | 13196f0a-6daf-4f62-853c-ac2ac261ce43 | 2025-09-12 | Adverse reactions | BETAMETHASONE DIPROPIONATE |
| Betamethasone Dipropionate | BETAMETHASONE DIPROPIONATE | Bryant Ranch Prepack | f2c557ea-275b-4ab4-90f4-4003e022214d | 2025-08-07 | Warnings, Adverse reactions | BETAMETHASONE DIPROPIONATE |
| BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | Bryant Ranch Prepack | 52c0e92f-986e-45e7-99cf-9a13ac386b1d | 2025-07-28 | Adverse reactions | BETAMETHASONE DIPROPIONATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0085-0962 | DIPROLENE | betamethasone dipropionate | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-0962 | DIPROLENE | betamethasone dipropionate | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-0962 | DIPROLENE | betamethasone dipropionate | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-0962 | DIPROLENE | betamethasone dipropionate | Merck Sharp & Dohme Corp. | NDA | Current |
| 0085-0962 | DIPROLENE | betamethasone dipropionate | Merck Sharp & Dohme Corp. | NDA | Current |