Application 077565

Type
ANDA
Sponsor
DR REDDYS LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASENoNo
002ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 40MG BASENoNo
003ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 60MG BASENoNo
004ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDECAPSULE;ORALEQ 80MG BASENoNo

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

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
A077565-001ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02
A077565-002ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02
A077565-003ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02
A077565-004ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077565-001AB
A077565-002AB
A077565-003AB
A077565-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-0284e616aacf4f…
2026-09-14 22:38:342026-08A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-0284e616aacf4f…
2026-09-14 22:38:342026-08A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-0284e616aacf4f…
2026-09-14 22:38:342026-08A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-0284e616aacf4f…
2026-08-18 06:07:402026-07A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077565-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077565-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077565-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077565-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A077565-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077565-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077565-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-004AB15bbf6a4d5a75…

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
ziprasidoneZIPRASIDONEREMEDYREPACK INC.6665279a-32ab-43ce-a258-039a6779a1a22026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidoneZIPRASIDONEREMEDYREPACK INC.3834670f-cc31-4ed9-87ec-b631339ae18a2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack5d576819-cd14-4a61-8a2f-6b90d8eac07e2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidoneZIPRASIDONEREMEDYREPACK INC.48b54613-9b5f-4fcb-ba1f-22085ee0d8d12026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ZiprasidoneZIPRASIDONEMajor Pharmaceuticalsca55c149-5b9a-4144-b586-37cb5e84dc4e2026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidoneZIPRASIDONEDr. Reddy's Laboratories Limited396cb4a6-01a1-f73f-2a37-39df9067bf982026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidoneZIPRASIDONENorthStar Rx LLC0071a228-21cc-56a6-dcc9-a7a6ceea758c2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEREMEDYREPACK INC.56370be6-42a2-4962-acdc-22b7c6e0e7fe2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ndc (product): 70518-1835
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack14191e0d-8219-4f6e-b808-09c4804a82622026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ndc (product): 71335-1508
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fc9ffbc3-1f16-9265-e053-6294a90acfd22025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack48e6e141-66d3-4eab-b0bf-dfd1d44b48322023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565

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 2 of 2 · 116 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63739-988ziprasidone hydrochlorideziprasidone hydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-988ziprasidone hydrochlorideziprasidone hydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-988ziprasidone hydrochlorideziprasidone hydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-988ziprasidone hydrochlorideziprasidone hydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-988ziprasidone hydrochlorideziprasidone hydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
64725-0259ziprasidone hydrochlorideziprasidone hydrochlorideTYA PharmaceuticalsANDACurrent
68071-2715ziprasidone hydrochlorideziprasidone hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2716ziprasidone hydrochlorideziprasidone hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7363ziprasidone hydrochlorideziprasidone hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7363ziprasidone hydrochlorideziprasidone hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7363ziprasidone hydrochlorideziprasidone hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-1604ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1604ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1604ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1604ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1604ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1604ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1604ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1835ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1835ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1835ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1835ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1835ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2294ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2294ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2294ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2294ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2294ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2294ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2374ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2374ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2374ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2374ziprasidone hydrochlorideziprasidone hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-1508ziprasidone hydrochlorideziprasidone hydrochlorideBryant Ranch PrepackANDACurrent
71335-1508ziprasidone hydrochlorideziprasidone hydrochlorideBryant Ranch PrepackANDACurrent
71335-1508ziprasidone hydrochlorideziprasidone hydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9062ORIG2011-04-21