Application 019555

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPROLENE AF	BETAMETHASONE DIPROPIONATE	CREAM, AUGMENTED;TOPICAL	EQ 0.05% BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019555-001	DIPROLENE AF	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
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	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019555-001	DIPROLENE AF	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019555-001	DIPROLENE AF	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019555-001	DIPROLENE AF	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RLD, RS	1987-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019555-001	DIPROLENE AF	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019555-001	DIPROLENE AF	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019555-001	DIPROLENE AF	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019555-001	DIPROLENE AF	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019555-001	DIPROLENE AF	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RLD, RS	1987-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019555-001	DIPROLENE AF	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RLD, RS	1987-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019555-001	DIPROLENE AF	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RLD, RS	1987-04-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019555-001	DIPROLENE AF	EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM, AUGMENTED / TOPICAL		RLD	1987-04-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019555-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N019555-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019555-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019555-001	AB	1	`ea99ee380514…`

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.

Matched openFDA labels page 1 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Redpharm Drug	5718b3bd-77b3-8034-e063-6294a90af5e0	2026-07-21	Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	b5291e39-40a0-4362-9281-97f5fb4025d9	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	Aurobindo Pharma Limited	a4f8db3a-0aed-451c-98ba-c4ce37656792	2026-05-04	Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Sernivo	BETAMETHASONE DIPROPIONATE	Primus Pharmaceuticals, Inc.	b1b3d1b0-da9b-11eb-ad76-0800200c9a66	2026-04-22	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Preferred Pharmaceuticals, Inc.	5683885d-461c-4e7e-bbe8-dc231d706192	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Preferred Pharmaceuticals, Inc.	54eff1fc-c611-4929-bb44-c1834c08f506	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	abd5a08c-4bb7-46c9-9e2e-0a89c43d46c8	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: 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	Name fallback generic name: 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	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Prasco Laboratories	f5b50c00-cc6f-4296-a9ae-b16888cef4dd	2025-11-19	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
DIPROLENE	BETAMETHASONE DIPROPIONATE	Organon LLC	0b9543ad-2ca7-430d-aef9-81c376dc2e6c	2025-11-19	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Lupin Pharmaceuticals, Inc.	216d5b7f-4236-4882-b899-be17cb1a1584	2025-11-13	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Encube Ethicals, Inc.	7e946599-2fb4-4426-bb59-fbb71d89dac8	2025-11-11	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	1d40b962-5d97-4416-b46d-b0785acd261d	2025-10-21	Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	REMEDYREPACK INC.	7cacf0ec-3db9-48be-9a76-93ed4a1f042c	2025-09-29	Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Sun Pharmaceutical Industries, Inc.	000ae256-a337-4903-845b-003777a4efa8	2025-09-26	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	13196f0a-6daf-4f62-853c-ac2ac261ce43	2025-09-12	Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	f2c557ea-275b-4ab4-90f4-4003e022214d	2025-08-07	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	52c0e92f-986e-45e7-99cf-9a13ac386b1d	2025-07-28	Adverse reactions	Name fallback generic name: BETAMETHASONE DIPROPIONATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0085-0517	DIPROLENE AF	betamethasone dipropionate	Merck Sharp & Dohme Corp.	NDA	Current
0085-0517	DIPROLENE AF	betamethasone dipropionate	Merck Sharp & Dohme Corp.	NDA	Current
0085-0517	DIPROLENE AF	betamethasone dipropionate	Merck Sharp & Dohme Corp.	NDA	Current
0085-0517	DIPROLENE AF	betamethasone dipropionate	Merck Sharp & Dohme Corp.	NDA	Current
0085-0517	DIPROLENE AF	betamethasone dipropionate	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58526	SUPPL	2019-05-02
58522	SUPPL	2019-05-02
53586	SUPPL	2018-04-01
53569	SUPPL	2018-04-01
11528	SUPPL	2014-08-15
17452	SUPPL	2014-08-14
17451	SUPPL	2006-09-18
33798	SUPPL	2006-08-28
33797	SUPPL	2001-10-03
33796	SUPPL	2001-10-03
20260	SUPPL	2001-10-03
20259	SUPPL	2001-10-03
17450	SUPPL	2001-10-03
17449	SUPPL	2001-10-03