Application 209274
- Type
- ANDA
- Sponsor
- GRANULES INDIA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-12-22 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | e64feba35796… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-0606 | Wal-Zyr | Cetirizine HCl | Walgreens | ANDA | Current |
| 0363-0606 | Allergy Relief | Cetirizine HCl | Walgreens | ANDA | Current |
| 0363-0606 | Wal-Zyr | Cetirizine HCl | Walgreens | ANDA | Current |
| 0363-0606 | Wal-Zyr | Cetirizine HCl | Walgreens | ANDA | Current |
| 0363-0606 | Wal-Zyr | Cetirizine HCl | Walgreens | ANDA | Current |
| 0363-9899 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | WALGREEN CO. | ANDA | Current |
| 0363-9899 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | WALGREEN CO. | ANDA | Current |
| 0363-9899 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | WALGREEN CO. | ANDA | Current |
| 41163-197 | Allergy Relief | Cetirizine hydrochloride | UNFI | ANDA | Current |
| 47682-204 | Medique Cetiramed | Cetirizine HCl | Unifirst First Aid Corporation | ANDA | Current |
| 47682-204 | Medique Cetiramed | Cetirizine HCl | Unifirst First Aid Corporation | ANDA | Current |
| 47682-204 | Medique Cetiramed | Cetirizine HCl | Unifirst First Aid Corporation | ANDA | Current |
| 50066-396 | Allergy Relief | Cetirizine HCl 10 mg | Genomma Labs USA, Inc | ANDA | Current |
| 50066-396 | Allergy Relief | Cetirizine HCl 10 mg | Genomma Labs USA, Inc | ANDA | Current |
| 50090-3906 | Allergy Relief | Cetirizine HCl | A-S Medication Solutions | ANDA | Current |
| 50090-3906 | Allergy Relief | Cetirizine HCl | A-S Medication Solutions | ANDA | Current |
| 50090-3906 | Allergy Relief | Cetirizine HCl | A-S Medication Solutions | ANDA | Current |
| 51824-076 | CAREALL Cetirizine HCl | Cetirizine | New World Imports | ANDA | Current |
| 51824-076 | CAREALL Cetirizine HCl | Cetirizine | New World Imports | ANDA | Current |
| 53329-033 | Medline | cetirizine hcl | Medline Industries, Inc. | ANDA | Current |
| 53329-033 | Medline | cetirizine hcl | Medline Industries, Inc. | ANDA | Current |
| 53329-033 | Medline | cetirizine hcl | Medline Industries, Inc. | ANDA | Current |
| 53329-033 | Medline | cetirizine hcl | Medline Industries, LP | ANDA | Current |
| 53329-033 | Medline | cetirizine hcl | Medline Industries, LP | ANDA | Current |
| 53943-194 | ALLERGY RELIEF | Cetirizine hydrochloride | DISCOUNT DRUG MART | ANDA | Current |
| 54257-270 | Allergy Relief | CETIRIZINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 54257-270 | Allergy Relief | CETIRIZINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 54257-270 | Allergy Relief | CETIRIZINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 55315-806 | Allergy Relief | Cetirizine HCl | Freds Inc | ANDA | Current |
| 55315-806 | Allergy Relief | Cetirizine HCl | Freds Inc | ANDA | Current |
| 55315-806 | Allergy Relief | Cetirizine HCl | Freds Inc | ANDA | Current |
| 55681-302 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | TWIN MED, LLC | ANDA | Current |
| 55681-302 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | TWIN MED, LLC | ANDA | Current |
| 57344-194 | Allergy Relief | Cetirizine hydrochloride | AAA PHARMACEUTICAL, INC. | ANDA | Current |
| 57344-194 | Allergy Relief | Cetirizine hydrochloride | AAA PHARMACEUTICAL, INC. | ANDA | Current |
| 59726-806 | All Day Allergy Relief | Cetirizine HCl | P & L Development, LLC | ANDA | Current |
| 59726-806 | All Day Allergy Relief | Cetirizine HCl | P & L Development, LLC | ANDA | Current |
| 59726-806 | All Day Allergy Relief | Cetirizine HCl | P & L Development, LLC | ANDA | Current |
| 62011-0384 | All Day Allergy Relief | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0384 | All Day Allergy Relief | Cetirizine HCl | McKesson (Health Mart) | ANDA | Current |
| 62011-0384 | All Day Allergy Relief | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 62207-764 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-764 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-764 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-764 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules India Ltd | ANDA | Current |
| 63868-665 | Allergy Relief | Cetirizine hydrochloride | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA | Current |
| 63868-665 | Allergy Relief | Cetirizine hydrochloride | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA | Current |
| 63941-194 | Allergy Relief | Cetirizine hydrochloride | VALU MERCHANDISERS COMPANY | ANDA | Current |
| 66424-564 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | SDA Laboratories, Inc. | ANDA | Current |
| 66715-6950 | 24 Hour Allergy | Cetirizine hydrochloride | Lil' Drug Store Products, Inc. | ANDA | Current |
| 66715-6950 | 24 Hour Allergy | Cetirizine hydrochloride | Lil' Drug Store Products, Inc. | ANDA | Current |
| 66715-6950 | 24 Hour Allergy | Cetirizine hydrochloride | Lil' Drug Store Products, Inc. | ANDA | Current |
| 67091-351 | Allergy Relief | Cetirizine HCl | WinCo Foods, LLC | ANDA | Current |
| 67091-351 | Allergy Relief | Cetirizine HCl | WinCo Foods, LLC | ANDA | Current |
| 68016-294 | Allergy Relief | Cetirizine hydrochloride | CHAIN DRUG CONSORTIUM | ANDA | Current |
| 68210-0119 | Cabinet Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-0119 | CABINET Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-0119 | CABINET Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-0119 | CABINET Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4219 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68210-4230 | Allergy Relief | Cetirizine Hydrochloride | Spirit Pharmaceutical LLC | ANDA | Current |
| 68998-194 | Allergy Relief | Cetirizine hydrochloride | MARC GLASSMAN, INC. | ANDA | Current |
| 68998-194 | Allergy Relief | Cetirizine hydrochloride | MARC GLASSMAN, INC. | ANDA | Current |
| 69168-396 | Allergy Relief | Cetirizine HCl 10 mg | Allegiant Health | ANDA | Current |
| 69168-396 | Allergy Relief | Cetirizine HCl 10 mg | Allegiant Health | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69230-304 | Allergy Relief | Cetirizine HCl | Camber Consumer Care | ANDA | Current |
| 69729-139 | Cetirizine hydrochloride | Cetirizine hydrochloride | OPMX LLC | ANDA | Current |
| 69729-139 | Cetirizine hydrochloride | Cetirizine hydrochloride | OPMX LLC | ANDA | Current |
| 69848-006 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Granules USA, Inc. | ANDA | Current |
| 70010-163 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-163 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-163 | Cetirizine hydrochloride | Cetirizine hydrochloride | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70518-2731 | Allergy Relief | CETIRIZINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2731 | Allergy Relief | CETIRIZINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |