Application 077565
- Type
- ANDA
- Sponsor
- DR REDDYS LABS INC
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 |
|---|---|---|---|---|---|---|---|
| A077565-001 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | |
| A077565-002 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | |
| A077565-003 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | |
| A077565-004 | ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-03-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077565-001 | AB |
| A077565-002 | AB |
| A077565-003 | AB |
| A077565-004 | 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 | A077565-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077565-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077565-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077565-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077565-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077565-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077565-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077565-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077565-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077565-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077565-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077565-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077565-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077565-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077565-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077565-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077565-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077565-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077565-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077565-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077565-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077565-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077565-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077565-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077565-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077565-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077565-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077565-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077565-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077565-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077565-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077565-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077565-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077565-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077565-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077565-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077565-001 | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077565-002 | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077565-003 | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077565-004 | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE / ORAL | AB | 2012-03-02 | 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 | A077565-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077565-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077565-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077565-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077565-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077565-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077565-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077565-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077565-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077565-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077565-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077565-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077565-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077565-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077565-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077565-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077565-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077565-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077565-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077565-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077565-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077565-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077565-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077565-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077565-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077565-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077565-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077565-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077565-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077565-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077565-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077565-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077565-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077565-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077565-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077565-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077565-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077565-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077565-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077565-004 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ziprasidone | ZIPRASIDONE | REMEDYREPACK INC. | 6665279a-32ab-43ce-a258-039a6779a1a2 | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | 077565 ANDA077565 |
| ziprasidone | ZIPRASIDONE | REMEDYREPACK INC. | 3834670f-cc31-4ed9-87ec-b631339ae18a | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 077565 ANDA077565 |
| ziprasidone hydrochloride | ZIPRASIDONE HYDROCHLORIDE | Bryant Ranch Prepack | 5d576819-cd14-4a61-8a2f-6b90d8eac07e | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | 077565 ANDA077565 |
| ziprasidone | ZIPRASIDONE | REMEDYREPACK INC. | 48b54613-9b5f-4fcb-ba1f-22085ee0d8d1 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 077565 ANDA077565 |
| Ziprasidone | ZIPRASIDONE | Major Pharmaceuticals | ca55c149-5b9a-4144-b586-37cb5e84dc4e | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 077565 ANDA077565 0904-6269 0904-6272 0904-6271 0904-6270 |
| ziprasidone | ZIPRASIDONE | Dr. Reddy's Laboratories Limited | 396cb4a6-01a1-f73f-2a37-39df9067bf98 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 077565 ANDA077565 55111-257 55111-256 55111-259 55111-258 |
| ziprasidone | ZIPRASIDONE | NorthStar Rx LLC | 0071a228-21cc-56a6-dcc9-a7a6ceea758c | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 077565 ANDA077565 16714-836 16714-838 16714-837 16714-835 |
| ziprasidone hydrochloride | ZIPRASIDONE HYDROCHLORIDE | REMEDYREPACK INC. | 56370be6-42a2-4962-acdc-22b7c6e0e7fe | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 077565 ANDA077565 |
| ziprasidone hydrochloride | ZIPRASIDONE HYDROCHLORIDE | Bryant Ranch Prepack | 14191e0d-8219-4f6e-b808-09c4804a8262 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | 077565 ANDA077565 |
| ziprasidone hydrochloride | ZIPRASIDONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fc9ffbc3-1f16-9265-e053-6294a90acfd2 | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | 077565 ANDA077565 |
| ziprasidone hydrochloride | ZIPRASIDONE HYDROCHLORIDE | Bryant Ranch Prepack | 48e6e141-66d3-4eab-b0bf-dfd1d44b4832 | 2023-09-07 | Boxed warning, Warnings, Adverse reactions | 077565 ANDA077565 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-7703 | ziprasidone hydrochloride | ziprasidone hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6269 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6269 | ziprasidone hydrochloride | ziprasidone hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6269 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6269 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6270 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6270 | ziprasidone hydrochloride | ziprasidone hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6270 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6270 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6271 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6271 | ziprasidone hydrochloride | ziprasidone hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6271 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6271 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6272 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6272 | ziprasidone hydrochloride | ziprasidone hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6272 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6272 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 16714-835 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-835 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-835 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-835 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-835 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-836 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-836 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-836 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-836 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-836 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-837 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-837 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-837 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-837 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-837 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-838 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-838 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-838 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-838 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-838 | ziprasidone hydrochloride | ziprasidone hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 50090-4821 | ziprasidone hydrochloride | ziprasidone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4821 | ziprasidone hydrochloride | ziprasidone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 55111-256 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-256 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-256 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-256 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-256 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-256 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-257 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-257 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-257 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-257 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-257 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-257 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-258 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-258 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-258 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-258 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-258 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-258 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-259 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-259 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-259 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-259 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-259 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-259 | ziprasidone hydrochloride | ziprasidone hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 61786-865 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 61786-867 | Ziprasidone Hydrochloride | Ziprasidone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 63739-005 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-005 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-005 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-005 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-005 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-508 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-508 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-508 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-508 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-508 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-666 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-666 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-666 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-666 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-666 | ziprasidone hydrochloride | ziprasidone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9062 | ORIG | 2011-04-21 |