Application 090961

Type
ANDA
Sponsor
CADILA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090961-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10
A090961-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090961-001AB
A090961-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10caaa826d4ba7…
2026-08-18 06:07:402026-07A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090961-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090961-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090961-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090961-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090961-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090961-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090961-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090961-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090961-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090961-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090961-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090961-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090961-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090961-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090961-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090961-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090961-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090961-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090961-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090961-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090961-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090961-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090961-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090961-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090961-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090961-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090961-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090961-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090961-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090961-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090961-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090961-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090961-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090961-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090961-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090961-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090961-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090961-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090961-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090961-002AB1bb7c543d1eb4…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEREMEDYREPACK INC.cbfd9d95-f50b-45ff-9857-9f1712c45e562026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 70518-3338
MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDEDirectRxd0839a2d-35f1-1f14-e053-2995a90ad5492026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 72189-294
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3662b11a-354a-b683-e063-6394a90a00862025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDECoupler LLC2d54be77-75b2-76b3-e063-6294a90a0cc02025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEZydus Lifesciences Limited514421f3-f525-43e8-aecc-8b2bbffd00dc2024-08-16Exact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 70771-1120
ndc (product): 70771-1119
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsf05e381f-850d-42ea-9dd8-6d1f8dac4f622024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 50090-6291
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack0ad2246a-ffa0-43a0-8094-58279d3e3a742024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackbe919d34-e9f4-49c8-8145-2dcafb7cb88c2024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack9cfddd01-6e1d-4ee0-9310-3fb371724e3d2023-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 71335-1732
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackbf395152-2885-4633-bf3f-2da46e7b79f12023-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 71335-1603
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack8bd5b908-f46a-4ced-9408-45984d7161492023-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 71335-2013
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe02023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 63629-2513
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack54a12ddf-306b-4eb7-a7c3-c7b58df3b3722023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 63629-2511
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackfac8c59b-5bf5-478e-8223-a5ecaa4006252023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 63629-2514
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackc8f96b24-de66-4a17-b798-42b42a25e84c2023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 63629-2512
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEViona Pharmaceuticals Incdcbdb62a-a4e2-4058-b73c-46005f2a5d512022-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 72578-004
ndc (product): 72578-003

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-6291Memantine HydrochlorideMemantine HydrochlorideA-S Medication SolutionsANDACurrent
63629-2511Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2511Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2512Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2512Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2513Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2513Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2514Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2514Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
68382-388Memantine HydrochlorideMemantine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-389Memantine HydrochlorideMemantine HydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7730Memantine HydrochlorideMemantine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7730Memantine HydrochlorideMemantine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7730Memantine HydrochlorideMemantine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-3338Memantine HydrochlorideMemantine HydrochlorideREMEDYREPACK INC.ANDACurrent
70771-1119Memantine HydrochlorideMemantine HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1119Memantine HydrochlorideMemantine HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1119Memantine HydrochlorideMemantine HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1119Memantine HydrochlorideMemantine HydrochlorideZydus Lifesciences LimitedANDACurrent
70771-1120Memantine HydrochlorideMemantine HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1120Memantine HydrochlorideMemantine HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1120Memantine HydrochlorideMemantine HydrochlorideCadila Healthcare LimitedANDACurrent
70771-1120Memantine HydrochlorideMemantine HydrochlorideZydus Lifesciences LimitedANDACurrent
71335-1603Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1603Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1603Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1732Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1732Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-2013Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
72189-294MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDEDirectRxANDACurrent
72578-003Memantine HydrochlorideMemantine HydrochlorideViona Pharmaceuticals IncANDACurrent
72578-003Memantine HydrochlorideMemantine HydrochlorideViona Pharmaceuticals IncANDACurrent
72578-003Memantine HydrochlorideMemantine HydrochlorideViona Pharmaceuticals IncANDACurrent
72578-004Memantine HydrochlorideMemantine HydrochlorideViona Pharmaceuticals IncANDACurrent
72578-004Memantine HydrochlorideMemantine HydrochlorideViona Pharmaceuticals IncANDACurrent
72578-004Memantine HydrochlorideMemantine HydrochlorideViona Pharmaceuticals IncANDACurrent