Application 077911

Type
ANDA
Sponsor
CARLSBAD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL1MGNoNo
002GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL2MGNoNo
003GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL4MGNoNo

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
A077911-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2009-09-22
A077911-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2009-09-22
A077911-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2009-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077911-001AB
A077911-002AB
A077911-003AB

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 UTC2026-02A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-228072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077911-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077911-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077911-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077911-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077911-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077911-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077911-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077911-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077911-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077911-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077911-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077911-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077911-001AB18072bd15b7f6…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.647a146c-c752-4589-8619-aed5c720ca542026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
ndc (product): 43063-699
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.ed7a3a8e-97dd-4a5a-9497-001acfd2f1f02026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
ndc (product): 43063-697
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.f4ffb19e-6d65-49fd-83ce-514d38d9d97c2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
ndc (product): 72789-048
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.11ae3189-6139-4470-95d5-72abc0f5b0d02025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
ndc (product): 43063-698
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.2794f86b-d521-414b-8154-5dd1e25196532025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
ndc (product): 43063-946
GlimepirideGLIMEPIRIDEGolden State Medical Supply, Inc.4f83e203-c102-47fa-bb8e-4fc5541e0d6f2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
ndc (product): 60429-920
ndc (product): 60429-918
ndc (product): 60429-919
GlimepirideGLIMEPIRIDECarlsbad Technology, Inc.72d88c6d-2f0a-4bf8-aa7f-1e18117941872024-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
ndc (product): 61442-116
ndc (product): 61442-117
ndc (product): 61442-115
GlimepirideGLIMEPIRIDEAphena Pharma Solutions - Tennessee, LLC00b9e312-921e-41e6-ad27-0a6ce87f82982019-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
ndc (product): 71610-236

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 60 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-6564GlimepirideGlimepirideLiberty Pharmaceuticals, Inc.ANDACurrent
0440-6565GlimepirideGlimepirideLiberty Pharmaceuticals, Inc.ANDACurrent
0440-6566GlimepirideGlimepirideLiberty Pharmaceuticals, Inc.ANDACurrent
33261-961GlimepirideGlimepirideAidarex Pharmaceuticals LLCANDACurrent
43063-697GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-697GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-697GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-697GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-697GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-697GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-698GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-698GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-698GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-698GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-698GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-698GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-698GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-699GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-699GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-699GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-699GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-699GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-699GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-699GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-946GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-946GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-946GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-946GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-946GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2485GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-2485GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-2486GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-2486GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
51655-103GLIMEPIRIDEGLIMEPIRIDENorthwind Pharmaceuticals, LLCANDACurrent
53217-320GlimepirideGlimepirideAidarex Pharmaceuticals LLCANDACurrent
53217-323GlimepirideGlimepirideAidarex Pharmaceuticals LLCANDACurrent
60429-918GlimepirideGlimepirideGolden State Medical Supply, Inc.ANDACurrent
60429-918GlimepirideGlimepirideGolden State Medical Supply, Inc.ANDACurrent
60429-918GlimepirideGlimepirideGolden State Medical Supply, Inc.ANDACurrent
60429-919GlimepirideGlimepirideGolden State Medical Supply, Inc.ANDACurrent
60429-919GlimepirideGlimepirideGolden State Medical Supply, Inc.ANDACurrent
60429-919GlimepirideGlimepirideGolden State Medical Supply, Inc.ANDACurrent
60429-920GlimepirideGlimepirideGolden State Medical Supply, Inc.ANDACurrent
60429-920GlimepirideGlimepirideGolden State Medical Supply, Inc.ANDACurrent
60429-920GlimepirideGlimepirideGolden State Medical Supply, Inc.ANDACurrent
61442-115GlimepirideGlimepirideCarlsbad Technology, Inc.ANDACurrent
61442-115GlimepirideGlimepirideCarlsbad Technology, Inc.ANDACurrent
61442-115GlimepirideGlimepirideCarlsbad Technology, Inc.ANDACurrent
61442-116GlimepirideGlimepirideCarlsbad Technology, Inc.ANDACurrent
61442-116GlimepirideGlimepirideCarlsbad Technology, Inc.ANDACurrent
61442-116GlimepirideGlimepirideCarlsbad Technology, Inc.ANDACurrent
61442-117GlimepirideGlimepirideCarlsbad Technology, Inc.ANDACurrent
61442-117GlimepirideGlimepirideCarlsbad Technology, Inc.ANDACurrent
61442-117GlimepirideGlimepirideCarlsbad Technology, Inc.ANDACurrent
70518-0907GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
70518-0907GlimepirideGlimepirideREMEDYREPACK INC.ANDACurrent
71610-236GlimepirideGlimepirideAphena Pharma Solutions - Tennessee, LLCANDACurrent
72789-048GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-048GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-048GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent