Home Applications 070541 Application 070541
Type ANDA
Sponsor TEVA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EPITOL CARBAMAZEPINE TABLET;ORAL 200MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070541-001 EPITOL CARBAMAZEPINE 200MG TABLET / ORAL AB 1986-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070541-001 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.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table 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 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070541-001 EPITOL 200MG TABLET / ORAL AB 1986-09-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-0090 Epitol Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0090 Epitol Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0090 Epitol Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0090 Epitol Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0090 Epitol Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0090 Epitol Carbamazepine Teva Pharmaceuticals USA, ANDA Current 0093-0109 Carbamazepine Carbamazepine Teva Pharmaceuticals USA, ANDA Current 0093-0109 Carbamazepine Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0109 Carbamazepine Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0109 Carbamazepine Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0109 Carbamazepine Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0109 Carbamazepine Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0109 Carbamazepine Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0093-0109 Carbamazepine Carbamazepine Teva Pharmaceuticals USA, Inc. ANDA Current 0615-3505 Carbamazepine Carbamazepine NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 51079-385 Carbamazepine Carbamazepine Mylan Institutional Inc. ANDA Current 51079-385 Carbamazepine Carbamazepine Mylan Institutional Inc. ANDA Current 51079-385 Carbamazepine Carbamazepine Mylan Institutional Inc. ANDA Current 63629-8753 Carbamazepine Carbamazepine Bryant Ranch Prepack ANDA Current 63629-8753 Carbamazepine Carbamazepine Bryant Ranch Prepack ANDA Current 67046-086 Carbamazepine Carbamazepine Contract Pharmacy Services-PA ANDA Current