Application 203346

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALPRAZOLAMALPRAZOLAMTABLET;ORAL0.25MGNoNo
002ALPRAZOLAMALPRAZOLAMTABLET;ORAL0.5MGNoNo
003ALPRAZOLAMALPRAZOLAMTABLET;ORAL1MGNoNo
004ALPRAZOLAMALPRAZOLAMTABLET;ORAL2MGNoNo

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

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
A203346-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31
A203346-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31
A203346-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORALAB2015-07-31
A203346-004ALPRAZOLAMALPRAZOLAM2MGTABLET / ORALAB2015-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203346-001AB
A203346-002AB
A203346-003AB
A203346-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-31d8e5a09893c0…

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
2026-08-18 06:07:402026-07A203346-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203346-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203346-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203346-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203346-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203346-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203346-004AB1d8e5a09893c0…

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMClinical Solutions Wholesale, LLC0cf8b567-201b-44fa-8fd3-c74023aff44f2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.4203d3fe-916e-41af-9daf-f58f4fed6f9c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
ndc (product): 72789-151
AlprazolamALPRAZOLAMSt. Mary's Medical Park Pharmacyfc5fe795-6b41-aecf-e053-6394a90af5622026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMBryant Ranch Prepack68d8b8d1-00a4-42c4-a796-90211fee1a6d2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
ndc (product): 71335-1894
AlprazolamALPRAZOLAMCoupler LLC5111e57d-8920-6861-e063-6294a90a21942026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMASCLEMED USA INC.8d76a554-7ed1-4c93-a5ea-30898aec0aa12026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMCoupler LLC509a8a86-d61c-3f05-e063-6394a90a52ca2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMBryant Ranch Prepack2bd0d4c6-0fde-46f2-bb13-da25d50427df2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMBryant Ranch Prepackd8364af1-d23e-4cd7-9a81-077ae97a951a2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMBryant Ranch Prepack0e2644fa-8334-4209-a63d-2466b5ab55b42026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
Alprazolam C-IVALPRAZOLAM C-IVDirect_Rxf6dd8005-1d50-41bc-e053-6394a90ac45b2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMProficient Rx LPc6795ed8-af28-41f4-b85b-48e1fe9d03692026-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMPreferredPharmaceuticals Inc.dc130aae-4510-4de7-a750-4a144e88208d2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMPreferred Pharmaceuticals Inc.73c1d1dc-ade2-4bb4-b109-83bd63acd15c2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMPreferred Pharmaceuticals Inc.78682252-e448-4b20-b49d-27c2c70e4cb32026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMNorthwind Health Company, LLC25174ee5-a86e-ab97-e063-6394a90acd872025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMAurobindo Pharma Limitedd2fd0b3e-9b78-44d0-82a6-96d6c62387502025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
ndc (product): 65862-676
ndc (product): 65862-678
ndc (product): 65862-677
ndc (product): 65862-679
AlprazolamALPRAZOLAMAvPAK3fa14fa4-45a7-6ef4-e063-6394a90a1dcd2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
Alprazolam C-IVALPRAZOLAM C-IVDirect_Rxf6dd0e94-4a79-769f-e053-6394a90a5ae62025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMNuCare Pharmaceuticals, Inc.315b5782-969a-4324-e063-6394a90acf372025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8215AlprazolamAlprazolamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8215AlprazolamAlprazolamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8215AlprazolamAlprazolamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8216AlprazolamAlprazolamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8216AlprazolamAlprazolamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8216AlprazolamAlprazolamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8216AlprazolamAlprazolamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8216AlprazolamAlprazolamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8295AlprazolamAlprazolamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8295AlprazolamAlprazolamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8295AlprazolamAlprazolamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8295AlprazolamAlprazolamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
60687-377AlprazolamAlprazolamAmerican Health PackagingANDACurrent
60687-377AlprazolamAlprazolamAmerican Health PackagingANDACurrent
60687-388AlprazolamAlprazolamAmerican Health PackagingANDACurrent
60687-388AlprazolamAlprazolamAmerican Health PackagingANDACurrent
64980-396AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
64980-396AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
64980-396AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
64980-397AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
64980-397AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
64980-397AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
64980-398AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
64980-398AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
64980-398AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
64980-399AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
64980-399AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
64980-399AlprazolamAlprazolamRising Pharmaceuticals, Inc.ANDACurrent
65862-676AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-676AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-676AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-676AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-676AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-677AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-677AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-677AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-677AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-677AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-678AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-678AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-678AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-678AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-678AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-679AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-679AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-679AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-679AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
65862-679AlprazolamAlprazolamAurobindo Pharma LimitedANDACurrent
71335-1894AlprazolamAlprazolamBryant Ranch PrepackANDACurrent
72789-151AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-151AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-151AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-151AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-151AlprazolamAlprazolamPD-Rx Pharmaceuticals, Inc.ANDACurrent