Application 209167

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TADALAFILTADALAFILTABLET;ORAL2.5MGNoNo
002TADALAFILTADALAFILTABLET;ORAL5MGNoNo
003TADALAFILTADALAFILTABLET;ORAL10MGNoNo
004TADALAFILTADALAFILTABLET;ORAL20MGNoNo

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
A209167-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A209167-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A209167-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-10-23
A209167-004TADALAFILTADALAFIL20MGTABLET / ORALAB12019-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209167-001AB1
A209167-002AB1
A209167-003AB1
A209167-004AB1

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209167-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A209167-002TADALAFIL5MGTABLET / ORALAB12019-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A209167-003TADALAFIL10MGTABLET / ORALAB12019-10-2384e616aacf4f…
2026-09-14 22:38:342026-08A209167-004TADALAFIL20MGTABLET / ORALAB12019-03-2684e616aacf4f…
2026-08-18 06:07:402026-07A209167-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A209167-002TADALAFIL5MGTABLET / ORALAB12019-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A209167-003TADALAFIL10MGTABLET / ORALAB12019-10-23caaa826d4ba7…
2026-08-18 06:07:402026-07A209167-004TADALAFIL20MGTABLET / ORALAB12019-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209167-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209167-002TADALAFIL5MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209167-003TADALAFIL10MGTABLET / ORALAB12019-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209167-004TADALAFIL20MGTABLET / ORALAB12019-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209167-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209167-002TADALAFIL5MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209167-003TADALAFIL10MGTABLET / ORALAB12019-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209167-004TADALAFIL20MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209167-001TADALAFIL2.5MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209167-002TADALAFIL5MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209167-003TADALAFIL10MGTABLET / ORALAB12019-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209167-004TADALAFIL20MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209167-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209167-002TADALAFIL5MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209167-003TADALAFIL10MGTABLET / ORALAB12019-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209167-004TADALAFIL20MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209167-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209167-002TADALAFIL5MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209167-003TADALAFIL10MGTABLET / ORALAB12019-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209167-004TADALAFIL20MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209167-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209167-002TADALAFIL5MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209167-003TADALAFIL10MGTABLET / ORALAB12019-10-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209167-004TADALAFIL20MGTABLET / ORALAB12019-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209167-001TADALAFIL2.5MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209167-002TADALAFIL5MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209167-003TADALAFIL10MGTABLET / ORALAB12019-10-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209167-004TADALAFIL20MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209167-001TADALAFIL2.5MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209167-002TADALAFIL5MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209167-003TADALAFIL10MGTABLET / ORALAB12019-10-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209167-004TADALAFIL20MGTABLET / ORALAB12019-03-265bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209167-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A209167-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A209167-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08A209167-004AB1184e616aacf4f…
2026-08-18 06:07:402026-07A209167-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A209167-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A209167-003AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A209167-004AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209167-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209167-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209167-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209167-004AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209167-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209167-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209167-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209167-004AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209167-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209167-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209167-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209167-004AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209167-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209167-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209167-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209167-004AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209167-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209167-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209167-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209167-004AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209167-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209167-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209167-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209167-004AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209167-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209167-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209167-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209167-004AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209167-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209167-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209167-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209167-004AB115bbf6a4d5a75…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILA-S Medication Solutionsa6847ad6-3b5b-47e5-a3b5-04dc3182d72b2026-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 50090-6150
TadalafilTADALAFILBryant Ranch Prepack07567ae5-7345-4ab1-9b2c-c586c4da04272026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 63629-8409
TadalafilTADALAFILBryant Ranch Prepackaa8d165b-0c7d-497a-b56a-7c62ebc0a5d22026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 71335-1587
TadalafilTADALAFILBryant Ranch Prepackf8def23c-55ea-4796-9735-dbcb251048352026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 71335-1620
TadalafilTADALAFILAccord Healthcare Inc.eedf3ad9-7d40-496d-b1a9-6200010c18e12026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 16729-369
ndc (product): 16729-370
ndc (product): 16729-371
ndc (product): 16729-372
TadalafilTADALAFILPreferred Pharmaceuticals Inc.affacb88-4af3-4ce9-961b-7fc37b169e9a2026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 68788-8153
TadalafilTADALAFILNorthwind Health Company, LLCf3092f5a-b976-91ab-e053-2995a90a9b502026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
TadalafilTADALAFILNorthwind Health Company, LLCf317fe1e-d7c4-fb8b-e053-2a95a90a54452026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
TadalafilTADALAFILNuCare Pharmaceuticals,Inc.cf35291b-b05b-1182-e053-2995a90a8dee2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 68071-2553
TadalafilTADALAFILNuCare Pharmaceuticals,Inc.9f83ea2e-8ee8-ab6d-e053-2995a90a1e962024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 68071-5186
TadalafilTADALAFILNuCare Pharmaceuticals,Inc.a0acad71-8ae3-2827-e053-2995a90a20b32024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 68071-5202
TadalafilTADALAFILProficient Rx LP7a105ef9-7129-4ce1-bd8d-ae316bf348e22022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 71205-720
TadalafilTADALAFILProficient Rx LPb539e862-d5d4-4989-a3dd-1eba66285d532022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 71205-502
TadalafilTADALAFILProficient Rx LP31c05a53-7282-46d0-81bd-108defe6fb382022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 71205-269
TadalafilTADALAFILProficient Rx LP6fa9d4fa-86c9-4791-b28b-78e8b9341cea2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 71205-268
TadalafilTADALAFILAsclemed USA, Inc.aba646fe-70c2-1abb-e053-2995a90aa16d2022-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209167
application number: ANDA209167
ndc (product): 76420-126

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 64 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-369TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-370TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-371TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-371TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-371TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-371TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-371TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
16729-372TadalafilTadalafilAccord Healthcare Inc.ANDACurrent
50090-6150TadalafilTadalafilA-S Medication SolutionsANDACurrent
50436-0370TadalafilTadalafilUnit Dose ServicesANDACurrent
50436-0370TadalafilTadalafilUnit Dose ServicesANDACurrent
50436-0372TadalafilTadalafilUnit Dose ServicesANDACurrent
63629-8409TadalafilTadalafilBryant Ranch PrepackANDACurrent
63629-8409TadalafilTadalafilBryant Ranch PrepackANDACurrent
63629-8409TadalafilTadalafilBryant Ranch PrepackANDACurrent
68071-2553TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5186TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5186TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5202TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5202TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5272TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5272TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8153TadalafilTadalafilPreferred Pharmaceuticals Inc.ANDACurrent
70518-2972TadalafilTadalafilREMEDYREPACK INC.ANDACurrent
70518-2972TadalafilTadalafilREMEDYREPACK INC.ANDACurrent
70934-795TadalafilTadalafilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-268TadalafilTadalafilProficient Rx LPANDACurrent
71205-268TadalafilTadalafilProficient Rx LPANDACurrent
71205-268TadalafilTadalafilProficient Rx LPANDACurrent
71205-268TadalafilTadalafilProficient Rx LPANDACurrent
71205-269TadalafilTadalafilProficient Rx LPANDACurrent
71205-269TadalafilTadalafilProficient Rx LPANDACurrent
71205-269TadalafilTadalafilProficient Rx LPANDACurrent
71205-269TadalafilTadalafilProficient Rx LPANDACurrent
71205-502TadalafilTadalafilProficient Rx LPANDACurrent
71205-502TadalafilTadalafilProficient Rx LPANDACurrent
71205-502TadalafilTadalafilProficient Rx LPANDACurrent
71205-720TadalafilTadalafilProficient Rx LPANDACurrent
71335-1587TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1587TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1587TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1620TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1620TadalafilTadalafilBryant Ranch PrepackANDACurrent
71455-597TADALAFILTADALAFILUNYTER ENTERPRISESANDACurrent
76420-126TadalafilTadalafilAsclemed USA, Inc.ANDACurrent
76420-126TadalafilTadalafilAsclemed USA, Inc.ANDACurrent