Application 077170
- Type
- ANDA
- Sponsor
- IVAX SUB TEVA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;120MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077170-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2008-02-25 | f41ea6bd6efb… |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0113-0176 | Good Sense All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | L. Perrigo Company | ANDA | Current |
| 0113-2176 | All Day Allergy-D | Cetirizine HCl, Pseudoephedrine HCl | L. Perrigo Company | ANDA | Current |
| 0363-0929 | Wal Zyr D | Cetirizine HCl, Pseudoephedrine HCl | Walgreen Company | ANDA | Current |
| 0363-0929 | Wal Zyr D | Cetirizine HCl, Pseudoephedrine HCl | Walgreen Company | ANDA | Current |
| 0904-5831 | All day Allergy d | Cetirizine HCl, Pseudoephedrine HCl | Major Pharmaceuticals | ANDA | Current |
| 11673-555 | up and up allergy plus congestion relief d | Cetirizine HCl, Pseudoephedrine HCl | Target Corporation | ANDA | Current |
| 11822-0566 | allergy and congestion relief d | Cetirizine HCl, Pseudoephedrine HCl | Rite Aid Corporation | ANDA | Current |
| 11822-0566 | allergy and congestion relief d | Cetirizine HCl, Pseudoephedrine HCl | Rite Aid Corporation | ANDA | Current |
| 11822-0566 | allergy and congestion relief d | Cetirizine HCl, Pseudoephedrine HCl | Rite Aid Corporation | ANDA | Current |
| 21130-176 | Signature Care Allergy Relief D | Cetirizine HCl, Pseudoephedrine HCl | Safeway | ANDA | Current |
| 21130-176 | Signature Care Allergy Relief D | Cetirizine HCl, Pseudoephedrine HCl | Safeway | ANDA | Current |
| 24385-175 | Good Neighbor Pharmacy All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | Amerisource Bergen | ANDA | Current |
| 24385-175 | Good Neighbor Pharmacy All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | Amerisource Bergen | ANDA | Current |
| 24385-175 | Good Neighbor Pharmacy All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | Amerisource Bergen | ANDA | Current |
| 30142-176 | all day allergy d | Cetirizine HCl, Pseudoephedrine HCl | Kroger Company | ANDA | Current |
| 36800-176 | Topcare All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | Topco Associates LLC | ANDA | Current |
| 36800-176 | Topcare All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | Topco Associates LLC | ANDA | Current |
| 37012-176 | Allergy Relief D | Cetirizine HCl, Pseudoephedrine HCl | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37012-176 | Allergy Relief D | Cetirizine HCl, Pseudoephedrine HCl | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37205-827 | Leader Allergy D 12 | Cetirizine HCl, Pseudoephedrine HCl | Cardinal Health | ANDA | Current |
| 37205-827 | Leader Allergy D 12 | Cetirizine HCl, Pseudoephedrine HCl | Cardinal Health | ANDA | Current |
| 37808-176 | all day Allergy Relief D | Cetirizine HCl, Pseudoephedrine HCl | H E B | ANDA | Current |
| 37808-785 | allergy relief d | Cetirizine HCl, Pseudoephedrine HCl | H E B | ANDA | Current |
| 37808-785 | allergy relief d | Cetirizine HCl, Pseudoephedrine HCl | H E B | ANDA | Current |
| 41163-176 | Equaline All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | Supervalu Inc | ANDA | Current |
| 41163-176 | Equaline All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | Supervalu Inc | ANDA | Current |
| 41190-176 | ShopRite Allergy D 12 | Cetirizine HCl, Pseudoephedrine HCl | Wakefern Food Corporation | ANDA | Current |
| 41190-176 | ShopRite Allergy D 12 | Cetirizine HCl, Pseudoephedrine HCl | Wakefern Food Corporation | ANDA | Current |
| 41250-299 | 12 hour allergy d | Cetirizine HCl, Pseudoephedrine HCl | Meijer Distribution Inc | ANDA | Current |
| 41520-091 | CareOne Allergy Relief D | Cetirizine HCl, Pseudoephedrine HCl | American Sales Company | ANDA | Current |
| 41520-091 | CareOne Allergy Relief D | Cetirizine HCl, Pseudoephedrine HCl | American Sales Company | ANDA | Current |
| 41520-091 | CareOne Allergy Relief D | Cetirizine HCl, Pseudoephedrine HCl | American Sales Company | ANDA | Current |
| 41520-355 | CareOne All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | American Sales Company | ANDA | Current |
| 42507-176 | All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | HyVee Inc | ANDA | Current |
| 42507-176 | All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | HyVee Inc | ANDA | Current |
| 45802-721 | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine HCl, Pseudoephedrine HCl | Perrigo New York Inc | ANDA | Current |
| 45802-721 | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine HCl, Pseudoephedrine HCl | Perrigo New York Inc | ANDA | Current |
| 45802-721 | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine HCl, Pseudoephedrine HCl | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 49348-851 | Sunmark All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | McKesson | ANDA | Current |
| 49348-851 | Sunmark All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 49738-709 | smart sense allergy relief d | Cetirizine HCl, Pseudoephedrine HCl | Kmart Corporation | ANDA | Current |
| 49738-709 | smart sense allergy relief d | Cetirizine HCl, Pseudoephedrine HCl | Kmart Corporation | ANDA | Current |
| 50090-1098 | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine HCl, Pseudoephedrine HCl | A-S Medication Solutions | ANDA | Current |
| 50090-1098 | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine HCl, Pseudoephedrine HCl | A-S Medication Solutions | ANDA | Current |
| 50090-1098 | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine HCl, Pseudoephedrine HCl | A-S Medication Solutions | ANDA | Current |
| 50090-2537 | Sunmark All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | A-S Medication Solutions | ANDA | Current |
| 50090-2537 | Sunmark All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | A-S Medication Solutions | ANDA | Current |
| 50090-2537 | Sunmark All Day Allergy D | Cetirizine HCl, Pseudoephedrine HCl | A-S Medication Solutions | ANDA | Current |
| 55316-176 | Healthy Accents Cetirizine-D | Cetirizine HCl, Pseudoephedrine HCl | DZA Brands LLC | ANDA | Current |
| 56062-176 | Allergy Relief D | Cetirizine HCl, Pseudoephedrine HCl | Publix Super Markets Inc | ANDA | Current |
| 59779-176 | Allergy Relief | Cetirizine HCl, Pseudoephedrine HCl | CVS Pharmacy | ANDA | Current |
| 59779-176 | Allergy Relief | Cetirizine HCl, Pseudoephedrine HCl | CVS Pharmacy | ANDA | Current |
| 62011-0055 | health mart allergy complete d | Cetirizine HCl, Pseudoephedrine HCl | McKesson | ANDA | Current |
| 62011-0055 | health mart allergy complete d | Cetirizine HCl, Pseudoephedrine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 63187-955 | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine HCl, Pseudoephedrine HCl | Proficient Rx LP | ANDA | Current |
| 63187-955 | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine HCl, Pseudoephedrine HCl | Proficient Rx LP | ANDA | Current |
| 63981-176 | Kirkland Signature Aller Tec D | Cetirizine HCl, Pseudoephedrine HCl | Costco Wholesale Company | ANDA | Current |
| 68258-8907 | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine HCl, Pseudoephedrine HCl | Dispensing Solutions, Inc. | ANDA | Current |
| 69256-176 | harris teeter all day allergy d | Cetirizine HCl, Pseudoephedrine HCl | Harris Teeter, LLC | ANDA | Current |
| 69256-176 | harris teeter all day allergy d | Cetirizine HCl, Pseudoephedrine HCl | Harris Teeter, LLC | ANDA | Current |
| 70000-0392 | leader allergy relief d | Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70000-0392 | leader allergy relief d | Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride | Cardinal Health | ANDA | Current |