Home Applications 075714 Application 075714
Type ANDA
Sponsor WOCKHARDT BIO AG Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CARBAMAZEPINE CARBAMAZEPINE SUSPENSION;ORAL 100MG/5ML 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 A075714-001 CARBAMAZEPINE CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075714-001 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 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075714-001 CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB 2002-06-05 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 · 2 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 0121-0862 Carbamazepine Carbamazepine PAI Holdings, LLC ANDA Current 0121-0862 Carbamazepine Carbamazepine Pharmaceutical Associates, Inc. ANDA Current 0121-0862 Carbamazepine Carbamazepine Pharmaceutical Associates, Inc. ANDA Current 0121-0862 Carbamazepine Carbamazepine Pharmaceutical Associates, Inc. ANDA Current 0121-0862 Carbamazepine Carbamazepine Pharmaceutical Associates, Inc. ANDA Current 0121-1724 Carbamazepine Carbamazepine PAI Holdings, LLC ANDA Current 0121-1724 Carbamazepine Carbamazepine Pharmaceutical Associates, Inc. ANDA Current 0121-1724 Carbamazepine Carbamazepine Pharmaceutical Associates, Inc. ANDA Current 0121-1724 Carbamazepine Carbamazepine Pharmaceutical Associates, Inc. ANDA Current 0121-1724 Carbamazepine Carbamazepine Pharmaceutical Associates, Inc. ANDA Current 17856-0029 CARBAMAZEPINE carbamazepine ATLANTIC BIOLOGICALS CORP. ANDA Current 17856-0029 CARBAMAZEPINE carbamazepine ATLANTIC BIOLOGICALS CORP. ANDA Current 60432-129 CARBAMAZEPINE carbamazepine Morton Grove Pharmaceuticals, Inc. ANDA Current 68094-007 Carbamazepine Carbamazepine Precision Dose, Inc. ANDA Current 68094-007 Carbamazepine Carbamazepine Precision Dose, Inc. ANDA Current 68094-007 Carbamazepine Carbamazepine Precision Dose, Inc. ANDA Current 68094-007 Carbamazepine Carbamazepine Precision Dose, Inc. ANDA Current 68094-008 Carbamazepine Carbamazepine Precision Dose, Inc. ANDA Current 68094-008 Carbamazepine Carbamazepine Precision Dose, Inc. ANDA Current 68094-008 Carbamazepine Carbamazepine Precision Dose, Inc. ANDA Current 68094-008 Carbamazepine Carbamazepine Precision Dose, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 24156 ORIG 2008-02-01