Allergy relief-D

Product NDC
70000-0163
11-digit product format
700000163
Labeler code
70000
Product ID
70000-0163_6a57686b-577f-4582-8ea4-9a533db38733
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health
Application
ANDA090922
Marketing category
ANDA
Marketing start
2017-05-02
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70000-0163DDiscontinued by firm2026-08-03
excluded packagepackage70000-016370000-0163-1DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70000-0163-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70000-0163-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70000-0163-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70000-0163-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70000-0163-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70000-0163-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70000-0163-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70000-0163-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70000-0163-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70000-0163-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70000-0163-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70000-0163-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70000-0163-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70000-0163-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70000-0163-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70000-0163-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70000-0163-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70000-0163-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage70000-0163-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage70000-0163-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage70000-0163-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28

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 UTC2026-02A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0163ALLERGY RELIEF-D (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]4Legacy NDC20170911_6cca410a-cad1-40a0-b9ef-a750a74a4929.zip

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDERITE AID1bf7c028-1648-4211-8847-84cce833a0f12025-01-02WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.c24f3760-70e0-410f-bf80-6d0cadcd61b92024-12-16WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.796c4b81-145b-4050-a851-dec81ff970062024-11-27WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC97997887-9cba-48f8-abcd-fdb86829459c2024-10-03WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
Wal-Zyr DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Company778ba62e-6cce-4d0f-b6d9-48b35ef40da72024-01-25WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
Allergy Relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS PHARMACY54a158e3-f545-4a01-bf8d-e72a286d734c2024-01-12WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECHAIN DRUG CONSORTIUM,LLC0f5de86d-1c87-4664-83f6-4c17f78f7d352018-11-30WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922