Application 205548

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	SUSPENSION/DROPS;OTIC	0.3%;0.1%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	CIPROFLOXACIN; DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB		2020-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205548-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205548-001	CIPROFLOXACIN AND DEXAMETHASONE	0.3%;0.1%	SUSPENSION/DROPS / OTIC	AB	2020-08-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205548-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205548-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205548-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205548-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205548-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205548-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205548-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205548-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205548-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205548-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205548-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205548-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205548-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205548-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205548-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205548-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205548-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205548-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205548-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205548-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205548-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205548-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205548-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205548-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205548-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205548-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205548-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205548-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205548-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205548-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205548-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205548-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205548-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205548-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205548-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205548-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205548-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205548-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205548-001	AB	1	`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.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	Sportpharm LLC	780a5554-54ef-4294-b681-8c5300b028b6	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205548 application number: ANDA205548
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	Redpharm Drug	546bf602-4b4c-cb08-e063-6394a90a2c55	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205548 application number: ANDA205548
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	NuCare Pharmaceuticals, Inc.	2f780550-ecbf-98fc-e063-6294a90a11c0	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205548 application number: ANDA205548
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	NorthStar RxLLC	130deaf4-ced5-abcb-2a01-205c640ddf96	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205548 application number: ANDA205548 ndc (product): 16714-628
Ciprofloxacin and Dexamethasone	CIPROFLOXACIN AND DEXAMETHASONE	Dr. Reddy's Laboratories, Inc.	f07cf7d6-c233-884e-342d-c6c8cd2c8438	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205548 application number: ANDA205548 ndc (product): 43598-326

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-628	Ciprofloxacin and Dexamethasone	Ciprofloxacin and Dexamethasone	NorthStar RxLLC	ANDA	Current
16714-628	Ciprofloxacin and Dexamethasone	Ciprofloxacin and Dexamethasone	NorthStar RxLLC	ANDA	Current
43598-326	Ciprofloxacin and Dexamethasone	Ciprofloxacin and Dexamethasone	Dr. Reddy's Laboratories, Inc.	ANDA	Current
43598-326	Ciprofloxacin and Dexamethasone	Ciprofloxacin and Dexamethasone	Dr. Reddy's Laboratories, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64606	ORIG	2020-09-18