Application 078020
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;80MG | No | No |
| 002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;160MG | No | No |
| 003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 25MG;160MG | No | No |
| 004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;320MG | No | No |
| 005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 25MG;320MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078020-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;80MG | TABLET / ORAL | AB | 2012-09-21 | |
| A078020-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;160MG | TABLET / ORAL | AB | 2012-09-21 | |
| A078020-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;160MG | TABLET / ORAL | AB | 2012-09-21 | |
| A078020-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;320MG | TABLET / ORAL | AB | 2012-09-21 | |
| A078020-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;320MG | TABLET / ORAL | AB | 2012-09-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078020-001 | AB |
| A078020-002 | AB |
| A078020-003 | AB |
| A078020-004 | AB |
| A078020-005 | 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 | A078020-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2012-09-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078020-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2012-09-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078020-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2012-09-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078020-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2012-09-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078020-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2012-09-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078020-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2012-09-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078020-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2012-09-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078020-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2012-09-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078020-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2012-09-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078020-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2012-09-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078020-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2012-09-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078020-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2012-09-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078020-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2012-09-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078020-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2012-09-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078020-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2012-09-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078020-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2012-09-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078020-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2012-09-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078020-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2012-09-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078020-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2012-09-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078020-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2012-09-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078020-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2012-09-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078020-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2012-09-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078020-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2012-09-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078020-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2012-09-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078020-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2012-09-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078020-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2012-09-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078020-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2012-09-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078020-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2012-09-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078020-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2012-09-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078020-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2012-09-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078020-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2012-09-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078020-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2012-09-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078020-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2012-09-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078020-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2012-09-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078020-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2012-09-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078020-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2012-09-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078020-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2012-09-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078020-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2012-09-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078020-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2012-09-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078020-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2012-09-21 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078020-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078020-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078020-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078020-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078020-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078020-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078020-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078020-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078020-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078020-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078020-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078020-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078020-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078020-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078020-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078020-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078020-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078020-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078020-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078020-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078020-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078020-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078020-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078020-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078020-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078020-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078020-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078020-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078020-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078020-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078020-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078020-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078020-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078020-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078020-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078020-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078020-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078020-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078020-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078020-005 | AB | 1 | 03ed91905a0d… |
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 |
|---|---|---|---|---|---|---|
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | f2b749a6-17ff-e044-e053-2995a90aea28 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 078020 ANDA078020 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | f835fa93-6529-c06d-e053-6394a90ad42a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 078020 ANDA078020 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 1b72ecfd-a08d-48c5-a853-d3bc9ff882f1 | 2023-05-09 | Boxed warning, Warnings, Adverse reactions | 078020 ANDA078020 50090-5985 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Mylan Pharmaceuticals Inc. | 3ba1f9f9-0037-4522-8605-e27dc8552b5b | 2023-04-27 | Boxed warning, Warnings, Adverse reactions | 078020 ANDA078020 0378-6321 0378-6322 0378-6325 0378-6323 0378-6324 |
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 |
|---|---|---|---|---|---|
| 0378-6321 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6321 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6321 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6321 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-6321 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6321 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6321 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6322 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6322 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6322 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6322 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-6322 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6322 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6322 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6323 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6323 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6323 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6323 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-6323 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6323 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6323 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6324 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6324 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6324 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6324 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-6324 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6324 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6324 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6325 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6325 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6325 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6325 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-6325 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6325 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6325 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 50090-5985 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 68788-7887 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7887 | Valsartan and Hydrochlorothiazide | valsartan and hydrochlorothiazide | Preferred Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9108 | ORIG | 2012-09-24 |