Application 208988
- Type
- ANDA
- Sponsor
- CADILA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | CAPSULE;ORAL | EQ 20MG BASE | No | No |
| 002 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | CAPSULE;ORAL | EQ 40MG BASE | No | No |
| 003 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | CAPSULE;ORAL | EQ 60MG BASE | No | No |
| 004 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | CAPSULE;ORAL | EQ 80MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208988-001 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | |
| A208988-002 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | |
| A208988-003 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | |
| A208988-004 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-08-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208988-001 | AB |
| A208988-002 | AB |
| A208988-003 | AB |
| A208988-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A208988-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208988-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208988-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208988-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208988-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208988-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208988-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208988-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208988-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208988-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208988-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208988-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208988-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208988-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208988-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208988-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208988-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208988-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208988-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208988-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208988-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208988-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208988-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208988-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208988-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208988-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208988-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208988-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208988-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208988-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208988-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208988-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208988-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208988-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208988-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208988-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208988-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208988-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208988-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208988-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2017-08-22 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A208988-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208988-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208988-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208988-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208988-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208988-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208988-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208988-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208988-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208988-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208988-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208988-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208988-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208988-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208988-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208988-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208988-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208988-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208988-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208988-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208988-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208988-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208988-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208988-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208988-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208988-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208988-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208988-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208988-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208988-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208988-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208988-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208988-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208988-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208988-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208988-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208988-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208988-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208988-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208988-004 | AB | 1 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|
| 68382-237 | Ziprasidone | Ziprasidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-237 | Ziprasidone | Ziprasidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-238 | Ziprasidone | Ziprasidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-238 | Ziprasidone | Ziprasidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-239 | Ziprasidone | Ziprasidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-239 | Ziprasidone | Ziprasidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-240 | Ziprasidone | Ziprasidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-240 | Ziprasidone | Ziprasidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1179 | Ziprasidone | Ziprasidone | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1179 | Ziprasidone | Ziprasidone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1179 | Ziprasidone | Ziprasidone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1180 | Ziprasidone | Ziprasidone | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1180 | Ziprasidone | Ziprasidone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1180 | Ziprasidone | Ziprasidone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1181 | Ziprasidone | Ziprasidone | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1181 | Ziprasidone | Ziprasidone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1181 | Ziprasidone | Ziprasidone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1182 | Ziprasidone | Ziprasidone | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1182 | Ziprasidone | Ziprasidone | Cadila Healthcare Limited | ANDA | Current |
| 70771-1182 | Ziprasidone | Ziprasidone | Cadila Healthcare Limited | ANDA | Current |
| 72578-020 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-020 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-021 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-021 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-022 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-022 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-023 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-023 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-125 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-125 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-126 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-126 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-127 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-127 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-128 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |
| 72578-128 | Ziprasidone | Ziprasidone | Viona Pharmaceuticals Inc | ANDA | Current |