Application 077568

Type
ANDA
Sponsor
FDC LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.3% BASENoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077568-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077568-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-303f01610625f2…
2019-09-15 20:21 UTC2019-09A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077568-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077568-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077568-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077568-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077568-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077568-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077568-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077568-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077568-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077568-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077568-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077568-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077568-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077568-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077568-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077568-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077568-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077568-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077568-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077568-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077568-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077568-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A077568-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077568-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077568-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077568-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A077568-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077568-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077568-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077568-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077568-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077568-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077568-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077568-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077568-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077568-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077568-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077568-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077568-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077568-001AT1e64feba35796…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ciprofloxacinCIPROFLOXACINHAWAII REPACK, INC4caf49d9-b06f-4d57-aac3-cc64ae12cc952026-07-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINRedpharm Drug541bd97e-b2ff-09a8-e063-6394a90aee962026-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINSportpharm LLC190395a8-c05f-4e31-9a89-7af6428ebbb92026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINPreferred Pharmaceuticals, Inc.85c48ebc-d94a-4254-86df-d2c1aff09b372026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ndc (product): 68788-7500
ciprofloxacinCIPROFLOXACINAdvanced Rx of Tennessee, LLC30cb2b42-aa4b-8cec-e063-6394a90aa6152025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINA-S Medication Solutions766251ac-2040-4a79-9ca5-a1e5f1e01cb52024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ndc (product): 50090-4217
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.7def5a45-6725-0521-e053-2991aa0a0bda2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ndc (product): 68071-4679
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.7d533171-0879-3854-e053-2a91aa0a3b462024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ndc (product): 68071-4672
ciprofloxacinCIPROFLOXACINLeading Pharma, LLC545527e7-05c7-4dbf-ab32-b3fa463d55b02024-05-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ndc (product): 69315-308
ciprofloxacinCIPROFLOXACINAsclemed USA, Inc.86c2ba30-9372-4e70-88a2-e6e1da07fa922023-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINProficient Rx LP05b2836d-cd3d-4d7f-970c-66ec2d7886672022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ndc (product): 71205-300

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-135CiprofloxacinCiprofloxacinPack Pharmaceuticals, LLCANDACurrent
45865-979ciprofloxacinCiprofloxacinmedsource pharmaceuticalsANDACurrent
45865-994ciprofloxacinCiprofloxacinmedsource pharmaceuticalsANDACurrent
50090-4217ciprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
50090-4217ciprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
50090-4220ciprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
50090-4220ciprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
50090-4769ciprofloxacinCiprofloxacinA-S Medication SolutionsANDACurrent
53002-7320ciprofloxacinCiprofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
55545-1011ciprofloxacinCiprofloxacinFDC LimitedANDACurrent
55700-737ciprofloxacinCiprofloxacinQuality Care Products, LLCANDACurrent
55700-737ciprofloxacinCiprofloxacinQuality Care Products, LLCANDACurrent
61919-795CIPROFLOXACINCIPROFLOXACINDirect_RxANDACurrent
61919-795CIPROFLOXACINCIPROFLOXACINDirect_RxANDACurrent
61919-795CIPROFLOXACINCIPROFLOXACINDirect_RxANDACurrent
68071-4672ciprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4672ciprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4679ciprofloxacinCiprofloxacinNuCare Pharmaceuticals,InANDACurrent
68071-4679ciprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4679ciprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4679ciprofloxacinCiprofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7500ciprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7500ciprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7500ciprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7500ciprofloxacinCiprofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
69315-308ciprofloxacinCiprofloxacinLeading Pharma, LLCANDACurrent
69315-308ciprofloxacinCiprofloxacinLeading Pharma, LLCANDACurrent
70518-2045ciprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-2045ciprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-2045ciprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-2045ciprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-2390ciprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-2390ciprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-2390ciprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
70518-2390ciprofloxacinCiprofloxacinREMEDYREPACK INC.ANDACurrent
71205-300ciprofloxacinCiprofloxacinProficient Rx LPANDACurrent
71205-300ciprofloxacinCiprofloxacinProficient Rx LPANDACurrent
71205-300ciprofloxacinCiprofloxacinProficient Rx LPANDACurrent