Application 071745

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 5MG BASENoNo
002PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 1MG BASENoNo
003PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDECAPSULE;ORALEQ 2MG BASENoNo

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

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
A071745-001PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12
A071745-002PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12
A071745-003PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071745-001AB
A071745-002AB
A071745-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-002PRAZOSIN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALAB1988-09-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-003PRAZOSIN HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB1988-09-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071745-001PRAZOSIN HYDROCHLORIDEEQ 5MG BASECAPSULE / ORALAB1988-09-121e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071745-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071745-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071745-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071745-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071745-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071745-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071745-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071745-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071745-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071745-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071745-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071745-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071745-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071745-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071745-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071745-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071745-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071745-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071745-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071745-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071745-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071745-001AB11e350fbaab3a…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.a3045d80-33f4-4aab-8dce-42fbbf9d3ef72026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
ndc (product): 70518-3352
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDECardinal Health 107, LLC879df2f9-d238-4cde-bbf8-82aef20fde3b2025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
ndc (product): 55154-8181
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.c8202658-422f-41db-bdee-7bb95b972b322025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
ndc (product): 68788-7335
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEAmerican Health Packaging2b9f51fb-da48-4c81-b6b7-eb74b9cbaaf42025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
ndc (product): 68084-997
ndc (product): 68084-996
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEAmerican Health Packaginga2b84746-f780-4e21-adc9-62d09c9363cf2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
ndc (product): 60687-572
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEBryant Ranch Prepackd58fd197-ca7a-481b-bf3c-0babb80db0232024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
ndc (product): 63629-8756
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEBryant Ranch Prepackce926a30-d417-4fc1-8aa3-71405f09ec5e2024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
ndc (product): 63629-8750
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEProficient Rx LPd7a9f9c3-fbb7-421e-ab65-fdd805a3197f2023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
ndc (product): 71205-585
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDETeva Pharmaceuticals USA, Inc.7293cef3-ef9e-40dc-9995-875ef047f6932018-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071745
application number: ANDA071745
ndc (product): 0093-4068
ndc (product): 0093-4067
ndc (product): 0093-4069

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-4067Prazosin HydrochloridePrazosin HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4067Prazosin HydrochloridePrazosin HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4068Prazosin HydrochloridePrazosin HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4068Prazosin HydrochloridePrazosin HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4069Prazosin HydrochloridePrazosin HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4069Prazosin HydrochloridePrazosin HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-0379Prazosin HydrochloridePrazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-0380Prazosin HydrochloridePrazosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-3533Prazosin HydrochloridePrazosin HydrochlorideA-S Medication SolutionsANDACurrent
55154-8181Prazosin HydrochloridePrazosin HydrochlorideCardinal HealthANDACurrent
55154-8181Prazosin HydrochloridePrazosin HydrochlorideCardinal HealthANDACurrent
55154-8181Prazosin HydrochloridePrazosin HydrochlorideCardinal Health 107, LLCANDACurrent
55700-492Prazosin HydrochloridePrazosin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-572Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
60687-572Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
61919-910PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEDIRECT RXANDACurrent
61919-910PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDEDIRECT RXANDACurrent
63629-6873Prazosin HydrochloridePrazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-6873Prazosin HydrochloridePrazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-8750Prazosin HydrochloridePrazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-8750Prazosin HydrochloridePrazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-8756Prazosin HydrochloridePrazosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-8756Prazosin HydrochloridePrazosin HydrochlorideBryant Ranch PrepackANDACurrent
68071-2914Prazosin HydrochloridePrazosin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68084-996Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
68084-996Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
68084-996Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
68084-996Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
68084-996Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
68084-997Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
68084-997Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
68084-997Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
68084-997Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
68084-997Prazosin HydrochloridePrazosin HydrochlorideAmerican Health PackagingANDACurrent
68788-7335Prazosin HydrochloridePrazosin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7335Prazosin HydrochloridePrazosin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7335Prazosin HydrochloridePrazosin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7335Prazosin HydrochloridePrazosin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7824Prazosin HydrochloridePrazosin HydrochlorideP)referred Pharmaceuticals Inc.ANDACurrent
68788-7824Prazosin HydrochloridePrazosin HydrochlorideP)referred Pharmaceuticals Inc.ANDACurrent
70518-3186Prazosin HydrochloridePrazosin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3352Prazosin HydrochloridePrazosin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3375Prazosin HydrochloridePrazosin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3375Prazosin HydrochloridePrazosin HydrochlorideREMEDYREPACK INC.ANDACurrent
71205-585Prazosin HydrochloridePrazosin HydrochlorideProficient Rx LPANDACurrent