Home Applications 079064 Application 079064
Type ANDA
Sponsor XIROMED Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 INTROVALE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG;0.15MG 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 A079064-001 INTROVALE ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079064-001 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 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079064-001 INTROVALE 0.03MG;0.15MG TABLET / ORAL AB 2010-09-27 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Introvale LEVONORGESTREL AND ETHINYL ESTRADIOL Xiromed, LLC. f5bc2427-3a18-e3e6-a058-210688e9c446 2022-06-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079064 application number: ANDA079064 ndc (product): 70700-117
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0781-5584 Introvale Levonorgestrel and Ethinyl Estradiol Sandoz Inc ANDA Current 70700-117 Introvale Levonorgestrel and Ethinyl Estradiol Xiromed, LLC. ANDA Current 70700-117 Introvale Levonorgestrel and Ethinyl Estradiol Xiromed, LLC. ANDA Current 70700-117 Introvale Levonorgestrel and Ethinyl Estradiol Xiromed, LLC. ANDA Current 70700-117 Introvale Levonorgestrel and Ethinyl Estradiol Xiromed, LLC. ANDA Current 70700-117 Introvale Levonorgestrel and Ethinyl Estradiol Xiromed, LLC. ANDA Current 70700-117 Introvale Levonorgestrel and Ethinyl Estradiol Xiromed, LLC. ANDA Current