Application 077528
- Type
- ANDA
- Sponsor
- TEVA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | CAPSULE;ORAL | EQ 25MG BASE;EQ 6MG BASE | No | No |
| 002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | CAPSULE;ORAL | EQ 25MG BASE;EQ 12MG BASE | No | No |
| 003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | CAPSULE;ORAL | EQ 50MG BASE;EQ 6MG BASE | No | No |
| 004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | CAPSULE;ORAL | EQ 50MG BASE;EQ 12MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077528-001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | |
| A077528-002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | |
| A077528-003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | RS | 2012-06-19 |
| A077528-004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE; OLANZAPINE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077528-001 | AB |
| A077528-002 | AB |
| A077528-003 | AB |
| A077528-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077528-001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077528-002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077528-003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | RS | 2012-06-19 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077528-004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077528-001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077528-002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077528-003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | RS | 2012-06-19 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077528-004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077528-001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077528-002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077528-003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | RS | 2012-06-19 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077528-004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077528-001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077528-002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077528-003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077528-004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077528-001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077528-002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077528-003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077528-004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077528-001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077528-002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077528-003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077528-004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077528-001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077528-002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077528-003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077528-004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077528-001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077528-002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077528-003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077528-004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077528-001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077528-002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077528-003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077528-004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077528-001 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077528-002 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 25MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077528-003 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 6MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077528-004 | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | EQ 50MG BASE;EQ 12MG BASE | CAPSULE / ORAL | AB | 2012-06-19 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077528-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077528-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077528-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077528-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077528-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077528-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077528-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077528-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077528-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077528-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077528-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077528-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077528-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077528-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077528-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077528-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077528-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077528-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077528-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077528-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077528-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077528-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077528-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077528-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077528-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077528-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077528-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077528-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077528-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077528-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077528-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077528-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077528-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077528-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077528-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077528-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077528-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077528-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077528-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077528-004 | AB | 1 | d06236e962d9… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Olanzapine and Fluoxetine | OLANZAPINE AND FLUOXETINE | Teva Pharmaceuticals USA, Inc. | 3c28cf18-01a3-468a-ab3e-8aa82f918251 | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 077528 ANDA077528 0093-5504 0093-5506 0093-5505 0093-5507 |
| Olanzapine and Fluoxetine | OLANZAPINE AND FLUOXETINE | AvKARE | f5f78ed2-4640-8528-c51c-d7bffa045d48 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 077528 ANDA077528 42291-656 42291-653 42291-654 42291-655 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-5504 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5504 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5504 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5504 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5504 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5504 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5504 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5504 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5505 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5505 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5505 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5505 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5505 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5505 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5505 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5505 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5506 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5506 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5506 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5506 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5506 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5506 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5506 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5506 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5507 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5507 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5507 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5507 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5507 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5507 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5507 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5507 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 42291-653 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | AvKARE, Inc. | ANDA | Current |
| 42291-653 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | AvKARE | ANDA | Current |
| 42291-654 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | AvKARE, Inc. | ANDA | Current |
| 42291-654 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | AvKARE | ANDA | Current |
| 42291-655 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | AvKARE, Inc. | ANDA | Current |
| 42291-655 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | AvKARE | ANDA | Current |
| 42291-656 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | AvKARE, Inc. | ANDA | Current |
| 42291-656 | Olanzapine and Fluoxetine | Olanzapine and Fluoxetine | AvKARE | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31258 | ORIG | 2012-06-22 |