Application 088618

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL25MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088618-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A088618-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-103f01610625f2…
2019-09-15 20:21 UTC2019-09A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRS1986-01-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088618-001HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALABRLD, RS1986-01-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A088618-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088618-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088618-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088618-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088618-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088618-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088618-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088618-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088618-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088618-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088618-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088618-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088618-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088618-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088618-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088618-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088618-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088618-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088618-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088618-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088618-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A088618-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088618-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088618-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088618-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A088618-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088618-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088618-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088618-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088618-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088618-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088618-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088618-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088618-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088618-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088618-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088618-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088618-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088618-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088618-001AB1cb3db0bc1861…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.ca67c061-c743-4ebb-a9d5-ece4880606632026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
ndc (product): 70518-2279
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDECardinal Health 107, LLCb4d274ce-d616-4835-80ce-76270524ed362026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Health Packaging47bda4fe-ddb7-4140-900a-970373cc7acc2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
ndc (product): 60687-675
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy1767a886-ec92-39fb-e063-6294a90a12492026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.6ad55cd1-a284-4c3d-aa90-653704afdb752026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
ndc (product): 70518-2066
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENorthwind Health Company, LLCdb0dce55-5984-7580-e053-2a95a90a36952026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack93d117dd-e2bf-4daa-abe3-d4fefed3313c2025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
ndc (product): 71335-0935
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack3f90259a-a684-498f-8963-d02eaba2e9db2025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
ndc (product): 63629-8740
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2b05bd0e-af57-4e74-92f8-a4311330142f2025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
ndc (product): 72789-216
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.80309ec1-e5d5-4454-b8ce-67d7e6805e442025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
ndc (product): 0093-5061
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LPd79be126-39cd-4dbb-ad88-0e4c18109dda2024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088618
application number: ANDA088618
ndc (product): 71205-155

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
10544-210HydroxyzineHydroxyzineBlenheim Pharmacal, Inc.ANDACurrent
50090-3286Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3286Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3362Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4404Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
53002-3200Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3200Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3900Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3900Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
60687-675Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Health PackagingANDACurrent
61919-743HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-743HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-743HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-743HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-743HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDIRECT RXANDACurrent
63629-7675Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8740Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8740Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
67296-0055Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRedPharm Drug Inc.ANDACurrent
67296-1681Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1681Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-2229Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2229Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4530HydrOXYzine HydrochlorideHydrOXYzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4530HydrOXYzine HydrochlorideHydrOXYzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4530HydrOXYzine HydrochlorideHydrOXYzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7464Hydroxyzine HydrochlorideHydroxyzine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7464Hydroxyzine HydrochlorideHydroxyzine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7464Hydroxyzine HydrochlorideHydroxyzine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2066Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2066Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2279Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2279Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2279Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2279Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2279Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-234Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-234Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-155Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71205-155Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71205-155Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71205-155Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71335-0935Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0935Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0935Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0935Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18523SUPPL2014-06-24
31434SUPPL2014-06-11
18522SUPPL2014-04-18