Application 085223

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDETABLET;ORAL20MGNoYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085223-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085223-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1986-07-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1986-07-303f01610625f2…
2019-09-15 20:21 UTC2019-09A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1986-07-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB1986-07-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085223-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALABRS1986-07-30cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A085223-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085223-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085223-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085223-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085223-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085223-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085223-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085223-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085223-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085223-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085223-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085223-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085223-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085223-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085223-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085223-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085223-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085223-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085223-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085223-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085223-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A085223-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085223-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085223-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085223-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A085223-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085223-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085223-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085223-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085223-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085223-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085223-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085223-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085223-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A085223-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A085223-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085223-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085223-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085223-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085223-001AB1cb3db0bc1861…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENorthwind Health Company, LLCc195b8ea-c1bf-453f-e053-2a95a90a21212026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085223
application number: ANDA085223
ndc (product): 51655-257
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.da0e1f63-cb90-4c2a-908f-7d81e672be102025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085223
application number: ANDA085223
ndc (product): 43063-045
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.517646d8-366e-5cf2-e054-00144ff88e882024-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085223
application number: ANDA085223
ndc (product): 68071-3255
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEActavis Pharma, Inc.a5937c7b-cdfc-46e6-a0fa-541b24f91d472024-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085223
application number: ANDA085223
ndc (product): 0591-0795
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEProficient Rx LPbd8b7fcd-04f4-4d1c-aa27-743aaf4c28762022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085223
application number: ANDA085223
ndc (product): 63187-784

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 64 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-0795Dicyclomine HydrochlorideDicyclomine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-0795Dicyclomine HydrochlorideDicyclomine HydrochlorideActavis Pharma, Inc.ANDACurrent
0615-7755Dicyclomine HydrochlorideDicyclomine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, InANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-045Dicyclomine HydrochlorideDicyclomine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-081Dicyclomine HydrochlorideDicyclomine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-081Dicyclomine HydrochlorideDicyclomine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0130Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0130Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0130Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0130Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2863Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
51655-257Dicyclomine HydrochlorideDicyclomine HydrochlorideNorthwind PharmaceuticalsANDACurrent
53002-3450Dicyclomine HydrochlorideDicyclomine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3450Dicyclomine HydrochlorideDicyclomine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53217-324Dicyclomine HydrochlorideDicyclomine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
53808-0234Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
58118-0795Dicyclomine HydrochlorideDicyclomine HydrochlorideClinical Solutions WholesaleANDACurrent
58118-0795Dicyclomine HydrochlorideDicyclomine HydrochlorideClinical Solutions WholesaleANDACurrent
58118-0795Dicyclomine HydrochlorideDicyclomine HydrochlorideClinical Solutions WholesaleANDACurrent
60760-631Dicyclomine HydrochlorideDicyclomine HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-795Dicyclomine HydrochlorideDicyclomine HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-324DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-324DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-324DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEDIRECT RXANDACurrent
63187-784Dicyclomine HydrochlorideDicyclomine HydrochlorideProficient Rx LPANDACurrent
63187-784Dicyclomine HydrochlorideDicyclomine HydrochlorideProficient Rx LPANDACurrent
63187-784Dicyclomine HydrochlorideDicyclomine HydrochlorideProficient Rx LPANDACurrent
63629-6820Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6820Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
67046-118Dicyclomine HydrochlorideDicyclomine HydrochlorideContract Pharmacy Services-PAANDACurrent
67296-0126Dicyclomine HydrochlorideDicyclomine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0126Dicyclomine HydrochlorideDicyclomine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-0126Dicyclomine HydrochlorideDicyclomine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-1908Dicyclomine HydrochlorideDicyclomine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3255Dicyclomine HydrochlorideDicyclomine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3255Dicyclomine HydrochlorideDicyclomine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-9525Dicyclomine HydrochlorideDicyclomine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9525Dicyclomine HydrochlorideDicyclomine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9525Dicyclomine HydrochlorideDicyclomine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9525Dicyclomine HydrochlorideDicyclomine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0100Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1596Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1596Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1596Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1596Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-682Dicyclomine HydrochlorideDicyclomine HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-682Dicyclomine HydrochlorideDicyclomine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0641Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0641Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0641Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
75921-795Dicyclomine HydrochlorideDicyclomine HydrochlorideLife Line Home Care Services, Inc.ANDACurrent