Application 204446

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 50MG BASENoNo
002DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 75MG BASENoNo
003DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 100MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204446-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28
A204446-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28
A204446-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-288072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204446-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204446-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204446-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204446-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204446-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204446-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204446-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204446-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204446-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204446-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204446-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204446-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204446-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204446-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204446-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204446-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204446-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204446-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204446-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204446-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204446-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204446-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A204446-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A204446-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204446-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A204446-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A204446-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204446-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A204446-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A204446-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204446-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A204446-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A204446-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204446-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A204446-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A204446-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204446-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A204446-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A204446-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204446-001AB16a51e52b5d6a…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXYCYCLINEDOXYCYCLINEDIRECT RX31512ece-cb16-2a9a-e054-00144ff88e882026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204446
application number: ANDA204446
ndc (product): 61919-276
DoxycyclineDOXYCYCLINELupin Pharmaceuticals,Inc.6512bf22-c211-4127-a8c8-2419656580f62024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204446
application number: ANDA204446
ndc (product): 43386-790
ndc (product): 43386-791
ndc (product): 43386-792

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 97 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0427DoxycyclineDoxycyclineG&W Laboratories, Inc.ANDACurrent
0713-0428DoxycyclineDoxycyclineG&W Laboratories, Inc.ANDACurrent
0713-0429DoxycyclineDoxycyclineG&W Laboratories, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineG&W Laboratories, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineG&W Laboratories, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0570DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0571DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0572DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
40032-790DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
40032-790DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
40032-791DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
40032-791DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
40032-792DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
40032-792DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
43063-681DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, InANDACurrent
43063-682DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, InANDACurrent
43063-886DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-886DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-886DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-886DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-886DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-985DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-985DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-985DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-985DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-985DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43386-790DoxycyclinedoxycyclineLupin Pharmaceuticals,Inc.ANDACurrent
43386-790DoxycyclinedoxycyclineGAVIS Pharmaceuticals, LLCANDACurrent
43386-791DoxycyclinedoxycyclineLupin Pharmaceuticals,Inc.ANDACurrent
43386-791DoxycyclinedoxycyclineGAVIS Pharmaceuticals, LLCANDACurrent
43386-792DoxycyclinedoxycyclineLupin Pharmaceuticals,Inc.ANDACurrent
43386-792DoxycyclinedoxycyclineGAVIS Pharmaceuticals, LLCANDACurrent
50090-2397DoxycyclineDoxycyclineA-S Medication SolutionsANDACurrent
50090-3443DoxycyclineDoxycyclineA-S Medication SolutionsANDACurrent
50090-5983DoxycyclineDoxycyclineA-S Medication SolutionsANDACurrent
53002-0670DoxycyclineDoxycyclineRPK Pharmaceuticals, Inc.ANDACurrent
53002-0670DoxycyclineDoxycyclineRPK Pharmaceuticals, Inc.ANDACurrent
53002-0672DoxycyclineDoxycyclineRPK Pharmaceuticals, Inc.ANDACurrent
54348-573DoxycyclineDOXYCYCLINEPharmPak, Inc.ANDACurrent
60760-431DoxycyclineDoxycyclineSt. Mary's Medical Park PharmacyANDACurrent
61919-276DOXYCYCLINEDOXYCYCLINEDIRECT RXANDACurrent
61919-276DOXYCYCLINEDOXYCYCLINEDIRECT RXANDACurrent
61919-276DOXYCYCLINEDOXYCYCLINEDIRECT RXANDACurrent
61919-276DOXYCYCLINEDOXYCYCLINEDIRECT RXANDACurrent
63187-936DoxycyclineDoxycyclineProficient Rx LPANDACurrent
63187-936DoxycyclineDoxycyclineProficient Rx LPANDACurrent
63629-7970DoxycyclineDoxycyclineBryant Ranch PrepackANDACurrent
63629-7970DoxycyclineDoxycyclineBryant Ranch PrepackANDACurrent
67296-1603DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1603DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1674DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1674DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1674DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
68071-2617DoxycyclineDoxycyclineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2617DoxycyclineDoxycyclineNuCare Pharmaceuticals,Inc.ANDACurrent
69668-431MondoxyneDoxycyclineOculus Innovative SciencesANDACurrent
69668-432MondoxyneDoxycyclineSonoma Pharmaceuticals, Inc.ANDACurrent
69668-433Mondoxyne NL 100mgDoxycyclineOculus Innovative SciencesANDACurrent
69668-452Mondoxyne NLDoxycyclineSonoma Pharmaceuticals, Inc.ANDACurrent
69668-452Mondoxyne NLDoxycyclineSonoma Pharmaceuticals, Inc.ANDACurrent
69668-453Mondoxyne NLDoxycyclineSonoma Pharmaceuticals, Inc.ANDACurrent
69668-453Mondoxyne NLDoxycyclineSonoma Pharmaceuticals, Inc.ANDACurrent
70934-178DoxycyclineDoxycyclineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-178DoxycyclineDoxycyclineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-178DoxycyclineDoxycyclineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-135DoxycyclineDoxycyclineProficient Rx LPANDACurrent
71205-135DoxycyclineDoxycyclineProficient Rx LPANDACurrent
71205-135DoxycyclineDoxycyclineProficient Rx LPANDACurrent
71205-135DoxycyclineDoxycyclineProficient Rx LPANDACurrent
71205-135DoxycyclineDoxycyclineProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32562ORIG2015-06-02