Application 078385
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | TABLET;ORAL | 12.5MG;50MG | No | No |
| 002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | TABLET;ORAL | 25MG;100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | |
| A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078385-001 | AB |
| A078385-002 | AB |
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 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078385-001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 12.5MG;50MG | TABLET / ORAL | AB | 2010-10-06 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078385-002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | AB | 2010-10-06 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | A078385-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A078385-002 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078385-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078385-002 | AB | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A078385-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A078385-002 | AB | 1 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | fd07d24c-6db1-4f6b-b226-68abba3a3321 | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 446e6998-01f6-4de0-be57-7fecf5448e95 | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 9f9cd7a7-be95-4ea8-8247-eb7ecbd36936 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Lupin Pharmaceuticals, Inc. | ee1eaaf6-050b-48af-942b-5e3451edc164 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | St. Mary's Medical Park Pharmacy | eac57b4c-e79b-8d35-e053-2a95a90a9d25 | 2026-06-21 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Camber Pharmaceuticals, Inc. | cdf59426-2a2f-4a60-943a-e6cef3eb31e1 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals Inc. | 6eab1c0a-9328-42a6-8eae-d4e105c54716 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | QPharma Inc | 8d2e01fe-6d4b-4c13-a03c-77f72b635715 | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | QPharma, Inc | 499208e5-21ab-d4fe-e063-6294a90a9a78 | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 03c0ec8d-9daf-43e8-8a4e-a2ddc3573ca7 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | be99cc03-ea65-4b17-bd9e-df7ae4307778 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 59801c48-2af7-4967-ae70-99f865551a7a | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 1d6712a3-bfb3-4081-b8f6-6057eb4baa27 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Direct Rx | d838e918-2463-79f6-e053-2a95a90a948d | 2026-03-05 | Warnings, Adverse reactions | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | dc9512cf-db66-40e9-afcb-1d6a722772e8 | 2026-02-14 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 5ec290f4-bf21-4c5b-a576-8eb2bd6bd379 | 2026-02-11 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Coupler LLC | 44fd38d2-cb8b-d0e8-e063-6294a90a994e | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | bc8b9ae2-8263-4624-8629-4f856392f9da | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Teva Pharmaceuticals USA, Inc. | deafd195-7a1b-4ad8-a371-2cd9f433dea5 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
| Losartan Potassium and Hydrochlorothiazide | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Alembic Pharmaceuticals Inc. | acecced9-2a61-435d-b7d4-b151cb7b7e5d | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | Losartan Potassium and Hydrochlorothiazide |
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 |
|---|---|---|---|---|---|
| 21695-831 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Rebel Distributors Corp | ANDA | Current |
| 50436-6665 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Unit Dose Services | ANDA | Current |
| 65841-732 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-732 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-732 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-732 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Zydus Lifesciences Limited | ANDA | Current |
| 65841-733 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-733 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-733 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-733 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Zydus Lifesciences Limited | ANDA | Current |
| 68382-142 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-142 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-142 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-142 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-143 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-143 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-143 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-143 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Zydus Pharmaceuticals USA Inc. | ANDA | Current |