Application 210907

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL10MGNoNo
003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL15MGNoNo
004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDETABLET;ORAL30MGNoNo

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
A210907-001BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14
A210907-002BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14
A210907-003BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-14
A210907-004BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210907-001AB
A210907-002AB
A210907-003AB
A210907-004AB

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
2026-09-14 22:38:342026-08A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-1484e616aacf4f…
2026-09-14 22:38:342026-08A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-1484e616aacf4f…
2026-09-14 22:38:342026-08A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-1484e616aacf4f…
2026-09-14 22:38:342026-08A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-1484e616aacf4f…
2026-08-18 06:07:402026-07A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-14caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALABRS2019-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-001BUSPIRONE HYDROCHLORIDE5MGTABLET / ORALAB2019-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-002BUSPIRONE HYDROCHLORIDE10MGTABLET / ORALAB2019-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-003BUSPIRONE HYDROCHLORIDE15MGTABLET / ORALAB2019-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-004BUSPIRONE HYDROCHLORIDE30MGTABLET / ORALAB2019-11-145bbf6a4d5a75…

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
2026-09-14 22:38:342026-08A210907-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A210907-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A210907-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A210907-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A210907-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210907-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210907-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210907-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210907-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210907-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210907-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210907-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210907-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210907-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210907-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210907-004AB15bbf6a4d5a75…

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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack20866697-58cd-4639-ae21-2fff486aec812025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fbd7f3fa-11f8-a319-e053-6294a90acae42025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HclBUSPIRONE HCLDirect Rxda584ae1-4513-6474-e053-2a95a90aac9d2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
ndc (product): 72189-235
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8afd9b8-0885-2f0c-e053-6294a90a9c572024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions932422a8-b72c-4dab-b942-2ab092ed6b012024-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
ndc (product): 50090-5797
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack38faa7cb-d858-4481-8649-35d228acbd382024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC19afb386-72a5-c97e-e063-6294a90adaea2024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions2a25a718-306f-403e-9928-cae30bc52f122024-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepacka2867dde-e5dd-4cc8-84d0-59240626868a2024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
ndc (product): 71335-1749
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackeab53fff-c052-4466-a673-3d68aab98c272024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
ndc (product): 71335-1924
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack5fa0720f-e236-4b8b-a0c0-6f48037c76b32024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
ndc (product): 71335-2060
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP1886b672-4b88-4b49-ae6a-d2ba2f452e442024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionsbce96786-4d9a-460e-8d92-9908ea2af07a2023-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.a6bdf140-075e-445e-a62d-633a4b97f3a82023-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210907
application number: ANDA210907
ndc (product): 29300-247
ndc (product): 29300-244
ndc (product): 29300-246
ndc (product): 29300-245

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-244Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-244Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-244Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-245Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-245Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-245Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-246Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-246Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-246Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-247Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-247Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-247Buspirone HydrochlorideBuspirone HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
50090-5762Buspirone HydrochlorideBuspirone HydrochlorideA-S Medication SolutionsANDACurrent
50090-5797Buspirone HydrochlorideBuspirone HydrochlorideA-S Medication SolutionsANDACurrent
55700-869Buspirone HydrochlorideBuspirone HydrochlorideQuality Care Products, LLCANDACurrent
55700-869Buspirone HydrochlorideBuspirone HydrochlorideQuality Care Products, LLCANDACurrent
55700-869Buspirone HydrochlorideBuspirone HydrochlorideQuality Care Products, LLCANDACurrent
55700-869Buspirone HydrochlorideBuspirone HydrochlorideQuality Care Products, LLCANDACurrent
68071-2572Buspirone HydrochlorideBuspirone HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7952Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7952Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7968Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7968Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8086Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8086Buspirone HydrochlorideBuspirone HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-2803Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2803Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3091Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3091Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3091Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3279Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3279Buspirone HydrochlorideBuspirone HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-1673Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1749Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1749Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-1924Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
71335-2060Buspirone HydrochlorideBuspirone HydrochlorideBryant Ranch PrepackANDACurrent
72189-235Buspirone HclBuspirone HclDirect RxANDACurrent
72189-235Buspirone HclBuspirone HclDirect RxANDACurrent
72189-235Buspirone HclBuspirone HclDirect RxANDACurrent