Application 205689

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 1MG BASENoNo
002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 2MG BASENoNo
003GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 3MG BASENoNo
004GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 4MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A205689-001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16
A205689-002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16
A205689-003GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16
A205689-004GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A205689-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205689-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205689-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205689-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205689-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205689-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205689-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205689-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205689-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205689-004AB1301d65b070ca…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuanfacineGUANFACINEBryant Ranch Prepackc20cc7eb-9de5-407a-8943-c4d2e3f784442026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
GuanfacineGUANFACINEBryant Ranch Prepack6e16cf54-c0d7-47ea-b502-c2146fd87f232026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
GuanfacineGUANFACINEBryant Ranch Prepackba58a5d0-607b-4dca-a63e-92d8dd81d81b2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
ndc (product): 63629-8203
GuanfacineGUANFACINEBryant Ranch Prepackf070a54a-2738-4ef2-a98a-f9e7a7a56f552026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
ndc (product): 63629-8161
GuanfacineGUANFACINESun Pharmaceutical Industries, Inc2d0a0f8e-5098-4ee2-a4ee-d026789923e22026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
ndc (product): 63304-926
ndc (product): 63304-927
ndc (product): 63304-924
ndc (product): 63304-925
GuanfacineGUANFACINEBryant Ranch Prepack9d558d8e-8b55-41c6-8209-62b1f7bb0dd42025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
GuanfacineGUANFACINENORTHSTAR RXLLC0b2afdab-8c92-463e-9734-f2c8b42007772024-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
ndc (product): 16714-190
ndc (product): 16714-192
ndc (product): 16714-191
ndc (product): 16714-193

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-190GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-190GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-191GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-191GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-192GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-192GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-193GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-193GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63629-1102GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1102GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1102GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1103GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1103GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1103GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1104GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1104GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1104GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1105GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1105GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1105GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1105GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-8161GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-8161GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-8203GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-8203GuanfacineGuanfacineBryant Ranch PrepackANDACurrent