Application 078032

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 5MG BASENoNo
002ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 10MG BASENoNo
003ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 20MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078032-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28
A078032-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28
A078032-003ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078032-001AB
A078032-002AB
A078032-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-2884e616aacf4f…
2026-09-14 22:38:342026-08A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-2884e616aacf4f…
2026-09-14 22:38:342026-08A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-2884e616aacf4f…
2026-08-18 06:07:402026-07A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2015-08-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2015-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2015-08-28301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078032-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078032-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078032-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078032-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078032-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078032-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078032-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078032-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078032-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078032-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078032-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078032-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078032-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078032-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078032-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078032-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078032-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078032-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078032-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078032-001AB1301d65b070ca…

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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAMDirect_Rxf75aabf8-f4a1-acd1-e053-6294a90ab9a62025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMAdvanced Rx Pharmacy of Tennessee, LLCf914fec5-4ce7-794d-e053-6294a90a7cc52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMBryant Ranch Prepack102c3893-4fdc-40b3-bd83-775e292723d72024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
ndc (product): 71335-1307
EscitalopramESCITALOPRAMBryant Ranch Prepackc842ec12-8792-47a9-82ad-9edf99e549ba2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
ndc (product): 71335-1187
EscitalopramESCITALOPRAMNuCare Pharmaceuticals,Inc.a489600b-6ae0-edb7-e053-2a95a90a7d002024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
ndc (product): 68071-5248
EscitalopramESCITALOPRAMA-S Medication Solutions2ffc6ec3-830f-46bc-9b3f-7c42cefa39b22024-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMA-S Medication Solutions575d7755-0518-4d48-bb1a-4ad01321fde72023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
EscitalopramESCITALOPRAMA-S Medication Solutions9b0b3c54-5bbc-4db9-9c69-00dac1347f242023-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032
ndc (product): 50090-5312
EscitalopramESCITALOPRAMProficient Rx LP3e3de8ea-b96b-456b-9336-69380fd2d0582023-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078032
application number: ANDA078032

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 79 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42708-155EscitalopramEscitalopramQPharma IncANDACurrent
43547-280EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-280EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-280EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-281EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-281EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-281EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-282EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-282EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-282EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
50090-5312EscitalopramEscitalopramA-S Medication SolutionsANDACurrent
50090-6190EscitalopramEscitalopramA-S Medication SolutionsANDACurrent
51655-284EscitalopramEscitalopramNorthwind PharmaceuticalsANDACurrent
51655-284EscitalopramEscitalopramNorthwind PharmaceuticalsANDACurrent
53002-2438EscitalopramEscitalopramRPK Pharmaceuticals, Inc.ANDACurrent
55700-818EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-818EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-818EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-818EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
60760-393EscitalopramEscitalopramSt. Mary's Medical Park PharmacyANDACurrent
63629-8241EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
67046-355EscitalopramEscitalopramContract Pharmacy Services-PAANDACurrent
67296-1408EscitalopramEscitalopramRedPharm Drug, Inc.ANDACurrent
67296-1421EscitalopramEscitalopramRedPharm Drug, Inc.ANDACurrent
67296-1597EscitalopramEscitalopramRedPharm Drug, Inc.ANDACurrent
67296-1597EscitalopramEscitalopramRedPharm Drug, Inc.ANDACurrent
68071-4984EscitalopramEscitalopramNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4984EscitalopramEscitalopramNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5248EscitalopramEscitalopramNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5248EscitalopramEscitalopramNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7461EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7461EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7461EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7461EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7510EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7510EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7510EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7510EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7559EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7559EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7559EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7559EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2317EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2317EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2317EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2317EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2430EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2430EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2430EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2472EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2472EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2472EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2597EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2597EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2597EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70934-630EscitalopramEscitalopramDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-646EscitalopramEscitalopramDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-650EscitalopramEscitalopramDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-1187EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1187EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1187EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1187EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1241EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1241EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1241EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1241EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1307EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1307EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1445EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1445EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1571EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1571EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1571EscitalopramEscitalopramBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31323ORIG2011-05-10
44370ORIG2007-01-18