Application 208885

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A208885-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB		2019-01-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A208885-001	AB

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208885-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208885-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208885-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208885-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208885-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208885-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208885-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208885-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208885-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208885-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208885-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208885-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208885-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208885-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208885-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208885-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208885-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208885-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208885-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208885-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208885-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208885-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208885-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208885-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208885-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208885-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208885-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208885-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208885-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208885-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208885-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208885-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208885-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208885-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208885-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208885-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208885-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208885-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208885-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208885-001	AB	1	`cb3db0bc1861…`

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Redpharm Drug	5718b3bd-77b3-8034-e063-6294a90af5e0	2026-07-21	Adverse reactions	Exact identifier application applno (ANDA): 208885 application number: ANDA208885
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	07a35811-7298-4f25-b280-e2f9aeab9830	2025-04-01	Adverse reactions	Exact identifier application applno (ANDA): 208885 application number: ANDA208885
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Northstar Rx LLC.	395d40c0-22d9-48d1-8d8e-eeaddf33c53e	2024-12-05	Adverse reactions	Exact identifier application applno (ANDA): 208885 application number: ANDA208885 ndc (product): 16714-996
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Zydus Lifesciences Limited	bc9ca1f4-8f40-44e1-bb2d-42ecba35d406	2024-11-25		Exact identifier application applno (ANDA): 208885 application number: ANDA208885 ndc (product): 70771-1380
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	1c15cbe5-51d6-4a1a-bb42-811f1d84ae66	2023-10-31	Adverse reactions	Exact identifier application applno (ANDA): 208885 application number: ANDA208885 ndc (product): 50090-4680
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Zydus Pharmaceuticals USA Inc.	18d80661-72ad-4a83-917f-a80ce37a5568	2022-10-05	Adverse reactions	Exact identifier application applno (ANDA): 208885 application number: ANDA208885 ndc (product): 70710-1233

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-996	Betamethasone dipropionate	Betamethasone dipropionate	Northstar Rx LLC.	ANDA	Current
16714-996	Betamethasone dipropionate	Betamethasone dipropionate	Northstar Rx LLC.	ANDA	Current
16714-996	Betamethasone dipropionate	Betamethasone dipropionate	Northstar Rx LLC.	ANDA	Current
50090-4679	Betamethasone dipropionate	Betamethasone dipropionate	A-S Medication Solutions	ANDA	Current
50090-4679	Betamethasone dipropionate	Betamethasone dipropionate	A-S Medication Solutions	ANDA	Current
50090-4679	Betamethasone dipropionate	Betamethasone dipropionate	A-S Medication Solutions	ANDA	Current
50090-4680	Betamethasone dipropionate	Betamethasone dipropionate	A-S Medication Solutions	ANDA	Current
50090-4680	Betamethasone dipropionate	Betamethasone dipropionate	A-S Medication Solutions	ANDA	Current
70518-3562	Betamethasone dipropionate	Betamethasone dipropionate	REMEDYREPACK INC.	ANDA	Current
70710-1233	Betamethasone dipropionate	Betamethasone dipropionate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1233	Betamethasone dipropionate	Betamethasone dipropionate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1233	Betamethasone dipropionate	Betamethasone dipropionate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1380	Betamethasone dipropionate	Betamethasone dipropionate	Cadila Healthcare Limited	ANDA	Current
70771-1380	Betamethasone dipropionate	Betamethasone dipropionate	Cadila Healthcare Limited	ANDA	Current
70771-1380	Betamethasone dipropionate	Betamethasone dipropionate	Zydus Lifesciences Limited	ANDA	Current