Application 075511

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINETABLET;ORAL20MGNoNo
002FAMOTIDINEFAMOTIDINETABLET;ORAL40MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075511-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORALAB2001-04-16
A075511-002FAMOTIDINEFAMOTIDINE40MGTABLET / ORALAB2001-04-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075511-001AB
A075511-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075511-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A075511-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075511-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075511-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075511-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075511-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075511-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075511-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075511-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075511-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075511-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075511-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075511-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075511-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075511-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075511-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075511-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075511-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075511-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075511-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075511-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075511-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075511-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075511-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075511-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075511-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075511-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075511-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075511-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075511-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075511-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075511-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075511-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075511-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075511-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075511-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075511-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075511-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075511-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075511-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075511-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075511-002AB1782e0a99824c…

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
FamotidineFAMOTIDINEProficient Rx LPd60bde93-f512-4071-9e4b-1d8318def3bc2026-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
ndc (product): 71205-276
FamotidineFAMOTIDINENorthwind Health Company, LLCf2b6da72-72ea-d81b-e053-2995a90a95262026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
FamotidineFAMOTIDINENorthwind Health Company, LLC03503cd5-bd8e-4bff-b90d-1a71c5225b912025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
ndc (product): 51655-102
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.5798d282-ce83-49aa-bc33-13203f2b52852025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
ndc (product): 43063-533
FamotidineFAMOTIDINEA-S Medication Solutions2bde8e1d-078f-4ba1-9ccb-29de6e36d8c42023-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
FamotidineFAMOTIDINEA-S Medication Solutions74ff64f2-d882-411f-bac8-29dfa4cb4f102023-08-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
ndc (product): 50090-1044
FamotidineFAMOTIDINEProficient Rx LPfe21daca-ac48-4b46-9cb3-9a69af0c6a842023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
FamotidineFAMOTIDINETeva Pharmaceuticals USA, Inc.4c6f4f9e-f3f5-4ecf-9f40-887e037e88472019-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075511
application number: ANDA075511
ndc (product): 0172-5728
ndc (product): 0172-5729

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 84 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0172-5728FamotidineFamotidineTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5728FamotidineFamotidineTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5728FamotidineFamotidineTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5728FamotidineFamotidineTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5729FamotidineFamotidineTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5729FamotidineFamotidineTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5729FamotidineFamotidineTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-5729FamotidineFamotidineTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-4582FamotidineFamotidineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-4582FamotidineFamotidineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-4582FamotidineFamotidineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-4594FamotidineFamotidineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8301FamotidineFamotidineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8301FamotidineFamotidineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
12634-967FamotidineFamotidineApotheca Inc.ANDACurrent
43063-086FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-086FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-086FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-086FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-086FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-533FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-533FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-533FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-533FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-533FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-881FamotidineFamotidinemedsource pharmaceuticalsANDACurrent
45865-881FamotidineFamotidinemedsource pharmaceuticalsANDACurrent
50090-1044FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-3305FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-3305FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-4389FamotidineFamotidineA-S Medication SolutionsANDACurrent
50436-0999FamotidineFamotidineUnit Dose ServicesANDACurrent
51655-102FamotidineFamotidineNorthwind Pharmaceuticals,LLCANDACurrent
51655-108FAMOTIDINEFAMOTIDINENorthwind PharmaceuticalsANDACurrent
55154-7552FamotidineFamotidineCardinal HealthANDACurrent
55289-765FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-765FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-765FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-765FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-7321FamotidineFamotidineBryant Ranch PrepackANDACurrent
67046-172FamotidineFamotidineContract Pharmacy Services-PAANDACurrent
67296-1121FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
67296-1121FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
67296-1121FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
67296-1121FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
68071-3181FamotidineFamotidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3181FamotidineFamotidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3181FamotidineFamotidineNuCare Pharmaceuticals,Inc.ANDACurrent
68645-140FamotidineFamotidineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-140FamotidineFamotidineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-140FamotidineFamotidineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-140FamotidineFamotidineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-140FamotidineFamotidineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-141FamotidineFamotidineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-141FamotidineFamotidineLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-6399FamotidineFamotidinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6399FamotidineFamotidinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6399FamotidineFamotidinePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0163FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-0163FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-0163FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-0163FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-0163FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-0163FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-0163FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-0163FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-0460FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-0460FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-0460FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-0460FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-1415FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-1415FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-1415FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-1415FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-1877FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70518-1877FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70934-780FamotidineFamotidineDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-819FamotidineFamotidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-819FamotidineFamotidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-276FamotidineFamotidineProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30919ORIG2001-04-16