Application 203844

Type
ANDA
Sponsor
CADILA PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATECAPSULE;ORALEQ 1.5MG BASENoNo
002RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATECAPSULE;ORALEQ 3MG BASENoNo
003RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATECAPSULE;ORALEQ 4.5MG BASENoNo
004RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATECAPSULE;ORALEQ 6MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203844-001RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13
A203844-002RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13
A203844-003RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13
A203844-004RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A203844-001AB
A203844-002AB
A203844-003AB
A203844-004AB

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-001RIVASTIGMINE TARTRATEEQ 1.5MG BASECAPSULE / ORALAB2017-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-002RIVASTIGMINE TARTRATEEQ 3MG BASECAPSULE / ORALAB2017-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-003RIVASTIGMINE TARTRATEEQ 4.5MG BASECAPSULE / ORALAB2017-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-004RIVASTIGMINE TARTRATEEQ 6MG BASECAPSULE / ORALAB2017-02-13d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203844-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203844-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203844-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203844-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203844-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203844-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203844-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203844-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203844-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203844-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203844-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203844-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203844-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203844-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203844-004AB1d8e5a09893c0…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rivastigmine TartrateRIVASTIGMINE TARTRATECadila Pharmaceuticals Limitede7e641fe-39bd-4681-a430-6dedeb6d6af52022-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203844
application number: ANDA203844
ndc (product): 71209-012
ndc (product): 71209-014
ndc (product): 71209-015
ndc (product): 71209-013
Rivastigmine TartrateRIVASTIGMINE TARTRATEModavar Pharmaceuticals LLC209f3b02-0acf-46e9-b355-91c918a20eb32022-12-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203844
application number: ANDA203844
ndc (product): 72241-014
ndc (product): 72241-013
ndc (product): 72241-011
ndc (product): 72241-012
RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a12022-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203844
application number: ANDA203844
ndc (product): 75834-136
ndc (product): 75834-135
ndc (product): 75834-133
ndc (product): 75834-134

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71209-012Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-012Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-012Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-012Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-012Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-013Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-013Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-013Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-013Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-013Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-014Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-014Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-014Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-014Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-014Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-015Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-015Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-015Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-015Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
71209-015Rivastigmine TartrateRivastigmine TartrateCadila Pharmaceuticals LimitedANDACurrent
72241-011Rivastigmine TartrateRivastigmine TartrateModavar Pharmaceuticals LLCANDACurrent
72241-011Rivastigmine TartrateRivastigmine TartrateModavar Pharmaceuticals LLCANDACurrent
72241-012Rivastigmine TartrateRivastigmine TartrateModavar Pharmaceuticals LLCANDACurrent
72241-012Rivastigmine TartrateRivastigmine TartrateModavar Pharmaceuticals LLCANDACurrent
72241-013Rivastigmine TartrateRivastigmine TartrateModavar Pharmaceuticals LLCANDACurrent
72241-013Rivastigmine TartrateRivastigmine TartrateModavar Pharmaceuticals LLCANDACurrent
72241-014Rivastigmine TartrateRivastigmine TartrateModavar Pharmaceuticals LLCANDACurrent
72241-014Rivastigmine TartrateRivastigmine TartrateModavar Pharmaceuticals LLCANDACurrent
75834-133RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent
75834-133RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent
75834-133RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent
75834-134RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent
75834-134RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent
75834-134RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent
75834-135RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent
75834-135RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent
75834-135RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent
75834-136RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent
75834-136RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent
75834-136RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATENivagen Pharmaceuticals, Inc.ANDACurrent