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 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
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 · 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 UTC2026-02A203346-001ALPRAZOLAM0.25MGTABLET / 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…
2024-10-29 15:01 UTC2024-10A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-31d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-10-29 15:01 UTC2024-10A203346-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203346-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203346-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203346-004AB1d06236e962d9…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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