Application 079121

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESCITALOPRAM OXALATEESCITALOPRAM OXALATESOLUTION;ORALEQ 5MG BASE/5MLNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079121-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORAL2012-05-03

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORAL2012-05-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORAL2012-05-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORAL2012-05-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-033f01610625f2…
2019-09-15 20:21 UTC2019-09A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079121-001ESCITALOPRAM OXALATEEQ 5MG BASE/5MLSOLUTION / ORALAA2012-05-03e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A079121-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079121-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079121-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079121-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079121-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079121-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079121-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079121-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079121-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079121-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079121-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079121-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079121-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079121-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079121-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079121-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079121-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079121-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079121-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A079121-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079121-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079121-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079121-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A079121-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079121-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079121-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079121-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079121-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079121-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079121-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079121-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079121-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A079121-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A079121-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079121-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079121-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079121-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079121-001AA1cb3db0bc1861…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAM OXALATESun Pharmaceutical Industries, Inc.c871d3fe-5ca2-410c-976d-9ec4b72c878f2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079121
application number: ANDA079121
ndc (product): 51672-1348

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51672-1348EscitalopramEscitalopram OxalateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1348EscitalopramEscitalopram OxalateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1348EscitalopramEscitalopram OxalateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent