Application 077836

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMFIBROZILGEMFIBROZILTABLET;ORAL600MGNoNo

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
A077836-001GEMFIBROZILGEMFIBROZIL600MGTABLET / ORALAB2006-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077836-001AB

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 UTC2026-02A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-273f01610625f2…
2019-09-15 20:21 UTC2019-09A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077836-001GEMFIBROZIL600MGTABLET / ORALAB2006-07-27cb3db0bc1861…

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 UTC2026-02A077836-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077836-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077836-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077836-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077836-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077836-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077836-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077836-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077836-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077836-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077836-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077836-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077836-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077836-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077836-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077836-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077836-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077836-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077836-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077836-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077836-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077836-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077836-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077836-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077836-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077836-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077836-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077836-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077836-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077836-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077836-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077836-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077836-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077836-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077836-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077836-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077836-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077836-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077836-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077836-001AB1cb3db0bc1861…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GemfibrozilGEMFIBROZILREMEDYREPACK INC.4260d746-bb58-4e10-9ffe-fc414f22b5912026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
ndc (product): 70518-1563
GemfibrozilGEMFIBROZILCoupler LLC509e6e7c-bb54-f135-e063-6294a90a52792026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILNorthwind Health Company, LLCa95264ab-eb86-7699-e053-2995a90a3d1f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
ndc (product): 51655-143
GemfibrozilGEMFIBROZILAmerican Health Packaging4e9e08da-9700-4934-a2b1-4f64c70ea8a22025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
ndc (product): 60687-224
GemfibrozilGEMFIBROZILAvPAK3ebb5947-1fe5-9740-6a4b-1f8b577b27112025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
ndc (product): 50268-350
GemfibrozilGEMFIBROZILPD-Rx Pharmaceuticals, Inc.5501438d-5247-4f2a-8e15-085276d017252025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
ndc (product): 43063-745
GemfibrozilGEMFIBROZILNuCare Pharmaceuticals,Inc.592811f2-e231-6a58-e053-2991aa0a69a92024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
ndc (product): 68071-1733
GemfibrozilGEMFIBROZILNuCare Pharmaceuticals, Inc.415ac7e0-ddc7-453e-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
ndc (product): 66267-436
GemfibrozilGEMFIBROZILProficient Rx LP7dbd38ab-7965-463f-9f8e-70efa8e071fb2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
ndc (product): 63187-772
GemfibrozilGEMFIBROZILExelan Pharmaceuticals, Inc.5c09fe54-697e-4cd5-9a26-7c9c7fa9a8642021-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILCipla USA Inc.05bfbcdc-03ab-4fba-9582-980602410ef92021-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
ndc (product): 69097-821
GemfibrozilGEMFIBROZILAphena Pharma Solutions - Tennessee, LLCeb1a2edf-587e-42c5-a98b-58646bc3f9482019-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836
GemfibrozilGEMFIBROZILAphena Pharma Solutions - Tennessee, LLC30a0d14a-f7a7-4ecf-99cd-6b907c8e0fe82018-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077836
application number: ANDA077836

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 93 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9130GemfibrozilGemfibrozilWest-ward Pharmaceutical CorpANDACurrent
0179-0221GemfibrozilGemfibrozilKAISER FOUNDATION HOSPITALSANDACurrent
21695-732GemfibrozilGemfibrozilRebel Distributors CorpANDACurrent
31722-225GemfibrozilGemfibrozilCamber PharmaceuticalsANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-745GemfibrozilGemfibrozilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-090GemfibrozilGemfibrozilAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0458GemfibrozilGemfibrozilA-S Medication SolutionsANDACurrent
50090-2902GemfibrozilGemfibrozilA-S Medication SolutionsANDACurrent
50090-2902GemfibrozilGemfibrozilA-S Medication SolutionsANDACurrent
50090-2902GemfibrozilGemfibrozilA-S Medication SolutionsANDACurrent
50090-2902GemfibrozilGemfibrozilA-S Medication SolutionsANDACurrent
50268-350GemfibrozilGemfibrozilAvPAKANDACurrent
50268-350GemfibrozilGemfibrozilAvPAKANDACurrent
51138-588GemfibrozilGemfibrozilMed-Health Pharma, LLCANDACurrent
51655-142GemfibrozilGemfibrozilNorthwind Pharmaceuticals, LLCANDACurrent
51655-143GemfibrozilGemfibrozilNorthwind Pharmaceuticals, LLCANDACurrent
51655-143GemfibrozilGemfibrozilNorthwind Pharmaceuticals, LLCANDACurrent
53002-1068GemfibrozilGemfibrozilRPK Pharmaceuticals, Inc.ANDACurrent
53002-1068GemfibrozilGemfibrozilRPK Pharmaceuticals, Inc.ANDACurrent
53217-251GemfibrozilGemfibrozilAidarex Pharmaceuticals LLCANDACurrent
53808-0673GemfibrozilGemfibrozilState of Florida DOH Central PharmacyANDACurrent
55700-493GemfibrozilGemfibrozilLake Erie Medical DBA QuaANDACurrent
55700-493GemfibrozilGemfibrozilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-493GemfibrozilGemfibrozilLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-493GemfibrozilGemfibrozilLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-224GemfibrozilGemfibrozilAmerican Health PackagingANDACurrent
60687-224GemfibrozilGemfibrozilAmerican Health PackagingANDACurrent
60687-224GemfibrozilGemfibrozilAmerican Health PackagingANDACurrent
60687-224GemfibrozilGemfibrozilAmerican Health PackagingANDACurrent
60687-224GemfibrozilGemfibrozilAmerican Health PackagingANDACurrent
61919-967GEMFIBROZILGEMFIBROZILdirect rxANDACurrent
61919-967GEMFIBROZILGEMFIBROZILDirect_RxANDACurrent
61919-967GEMFIBROZILGEMFIBROZILDirect_RxANDACurrent
61919-967GEMFIBROZILGEMFIBROZILDirect_RxANDACurrent
61919-967GEMFIBROZILGEMFIBROZILDirect_RxANDACurrent
61919-968GEMFIBROZILGEMFIBROZILDirectRXANDACurrent
61919-968GEMFIBROZILGEMFIBROZILDirectRXANDACurrent
63187-146GemfibrozilGemfibrozilProficient Rx LPANDACurrent
63187-146GemfibrozilGemfibrozilProficient Rx LPANDACurrent
63187-772GemfibrozilGemfibrozilProficient Rx LPANDACurrent
63187-772GemfibrozilGemfibrozilProficient Rx LPANDACurrent
63187-772GemfibrozilGemfibrozilProficient Rx LPANDACurrent
63187-772GemfibrozilGemfibrozilProficient Rx LPANDACurrent
66267-436GemfibrozilGemfibrozilNuCare Pharmaceuticals, Inc.ANDACurrent
66267-436GemfibrozilGemfibrozilNuCare Pharmaceuticals, Inc.ANDACurrent
66336-367GemfibrozilGemfibrozilDispensing Solutions, Inc.ANDACurrent
67046-231GemfibrozilGemfibrozilContract Pharmacy Services-PAANDACurrent
67046-233GemfibrozilGemfibrozilContract Pharmacy Services-PAANDACurrent
68071-1733GemfibrozilGemfibrozilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1733GemfibrozilGemfibrozilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4011GEMFIBROZILGEMFIBROZILNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4011GEMFIBROZILGEMFIBROZILNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4053GEMFIBROZILGEMFIBROZILNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4053GEMFIBROZILGEMFIBROZILNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4053GEMFIBROZILGEMFIBROZILNuCare Pharmaceuticals,Inc.ANDACurrent
68151-2893GemfibrozilGemfibrozilCarilion Materials ManagementANDACurrent
68788-6447GemfibrozilGemfibrozilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6447GemfibrozilGemfibrozilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6447GemfibrozilGemfibrozilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6447GemfibrozilGemfibrozilPreferred Pharmaceuticals Inc.ANDACurrent
68788-6447GemfibrozilGemfibrozilPreferred Pharmaceuticals Inc.ANDACurrent
68788-7011GEMFIBROZILGEMFIBROZILPreferred Pharmaceuticals Inc.ANDACurrent
68788-9149GemfibrozilGemfibrozilPreferred Pharmaceuticals, IncANDACurrent
69097-821GemfibrozilGemfibrozilCipla USA Inc.ANDACurrent
69097-821GemfibrozilGemfibrozilCipla USA Inc.ANDACurrent
69097-821GemfibrozilGemfibrozilCipla USA Inc.ANDACurrent
69097-821GemfibrozilGemfibrozilCipla USA Inc.ANDACurrent
70518-1301GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1301GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent
70518-1563GemfibrozilGemfibrozilREMEDYREPACK INC.ANDACurrent