Application 200295

Type
ANDA
Sponsor
SIGMAPHARM LABS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMTABLET;ORALEQ 0.005MG BASENoNo
002LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMTABLET;ORALEQ 0.025MG BASENoNo
003LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMTABLET;ORALEQ 0.05MG BASENoYes

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
A200295-001LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29
A200295-002LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29
A200295-003LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200295-001AB
A200295-002AB
A200295-003AB

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 UTC2026-02A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-002LIOTHYRONINE SODIUMEQ 0.025MG BASETABLET / ORALAB2012-11-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-003LIOTHYRONINE SODIUMEQ 0.05MG BASETABLET / ORALABRS2012-11-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200295-001LIOTHYRONINE SODIUMEQ 0.005MG BASETABLET / ORALAB2012-11-298072bd15b7f6…

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 UTC2026-02A200295-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200295-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200295-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200295-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200295-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200295-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200295-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200295-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200295-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200295-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200295-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200295-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200295-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200295-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200295-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200295-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200295-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200295-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200295-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200295-001AB18072bd15b7f6…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Liothyronine SodiumLIOTHYRONINE SODIUMPreferred Pharmaceuticals Inc.57744c7c-af44-4bc4-a5a8-79f05710f4692026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
ndc (product): 68788-7269
Liothyronine SodiumLIOTHYRONINE SODIUMASCLEMED USA INC.26cf6872-f4d4-41dd-8957-a000f13efbb32026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
LiomnyLIOTHYRONINE SODIUMSIGMAPHARM LABORATORIES, LLC0dcec611-2b7a-4cf3-80c3-7389be2f0a942025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMPD-Rx Pharmaceuticals, Inc.76fa4eb6-fefa-4e97-9543-f81e465743e62025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
ndc (product): 43063-884
Liothyronine SodiumLIOTHYRONINE SODIUMNuCare Pharmaceuticals,Inc.1133ebe8-38c2-2505-e063-6294a90aaa2f2024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMA-S Medication Solutionsdb65bcd8-e9c9-4095-9975-03be1f4438232024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
ndc (product): 50090-3131
Liothyronine SodiumLIOTHYRONINE SODIUMBryant Ranch Prepack31a11006-8122-49fc-8769-a28a359ac5262023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
ndc (product): 71335-0341
Liothyronine SodiumLIOTHYRONINE SODIUMBryant Ranch Prepack7efdd16d-37e6-4dc8-a6c5-5b42c48133792023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
ndc (product): 71335-0166
Liothyronine SodiumLIOTHYRONINE SODIUMBryant Ranch Prepack20cbf84d-80f2-4b94-ad47-6aaa362fb4d02023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
Liothyronine SodiumLIOTHYRONINE SODIUMProficient Rx LPf882d34f-6b9f-4d9d-8a3e-3054ba91c5062023-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
ndc (product): 71205-150
Liothyronine SodiumLIOTHYRONINE SODIUMSIGMAPHARM LABORATORIES, LLC38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c2023-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200295
application number: ANDA200295
ndc (product): 42794-019
ndc (product): 42794-020
ndc (product): 42794-018

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-417Liothyronine SodiumLiothyronine SodiumAvKARE, Inc.ANDACurrent
42291-417Liothyronine SodiumLiothyronine SodiumAvKARE, IncANDACurrent
42291-417Liothyronine SodiumLiothyronine SodiumAvKAREANDACurrent
42291-418Liothyronine SodiumLiothyronine SodiumAvKARE, Inc.ANDACurrent
42291-418Liothyronine SodiumLiothyronine SodiumAvKARE, IncANDACurrent
42291-418Liothyronine SodiumLiothyronine SodiumAvKAREANDACurrent
42291-419Liothyronine SodiumLiothyronine SodiumAvKARE, Inc.ANDACurrent
42291-419Liothyronine SodiumLiothyronine SodiumAvKARE, IncANDACurrent
42291-419Liothyronine SodiumLiothyronine SodiumAvKAREANDACurrent
42794-018Liothyronine SodiumLiothyronine SodiumSIGMAPHARM LABORATORIES, LLCANDACurrent
42794-018Liothyronine SodiumLiothyronine SodiumSIGMAPHARM LABORATORIES, LLCANDACurrent
42794-018Liothyronine SodiumLiothyronine SodiumSIGMAPHARM LABORATORIES, LLCANDACurrent
42794-019Liothyronine SodiumLiothyronine SodiumSIGMAPHARM LABORATORIES, LLCANDACurrent
42794-019Liothyronine SodiumLiothyronine SodiumSIGMAPHARM LABORATORIES, LLCANDACurrent
42794-019Liothyronine SodiumLiothyronine SodiumSIGMAPHARM LABORATORIES, LLCANDACurrent
42794-020Liothyronine SodiumLiothyronine SodiumSIGMAPHARM LABORATORIES, LLCANDACurrent
42794-020Liothyronine SodiumLiothyronine SodiumSIGMAPHARM LABORATORIES, LLCANDACurrent
42794-020Liothyronine SodiumLiothyronine SodiumSIGMAPHARM LABORATORIES, LLCANDACurrent
43063-884Liothyronine SodiumLiothyronine SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-884Liothyronine SodiumLiothyronine SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-884Liothyronine SodiumLiothyronine SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-884Liothyronine SodiumLiothyronine SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-884Liothyronine SodiumLiothyronine SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-884Liothyronine SodiumLiothyronine SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3131Liothyronine SodiumLiothyronine SodiumA-S Medication SolutionsANDACurrent
50090-3131Liothyronine SodiumLiothyronine SodiumA-S Medication SolutionsANDACurrent
51655-122LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMNorthwind PharmaceuticalsANDACurrent
51655-641liothyronine sodiumliothyronine sodiumNorthwind Pharmaceuticals, LLCANDACurrent
53217-361Liothyronine SodiumLiothyronine SodiumAidarex Pharmaceuticals LLCANDACurrent
63629-6391Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
63629-6391Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
63629-6391Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
63629-6391Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
63629-6540Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
63629-8154Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
63629-8154Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
63629-8154Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
68788-7269Liothyronine SodiumLiothyronine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7269Liothyronine SodiumLiothyronine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7269Liothyronine SodiumLiothyronine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7269Liothyronine SodiumLiothyronine SodiumPreferred Pharmaceuticals Inc.ANDACurrent
71205-150Liothyronine SodiumLiothyronine SodiumProficient Rx LPANDACurrent
71205-150Liothyronine SodiumLiothyronine SodiumProficient Rx LPANDACurrent
71335-0166Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
71335-0166Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
71335-0166Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
71335-0166Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
71335-0341Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
71335-0341Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent
71335-0341Liothyronine SodiumLiothyronine SodiumBryant Ranch PrepackANDACurrent