Home Applications 209112 Application 209112
Type NDA
Sponsor MCGUFF Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ASCOR ASCORBIC ACID SOLUTION;INTRAVENOUS 25,000MG/50ML (500MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N209112-001 ASCOR ASCORBIC ACID 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-10-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N209112-001 AP
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 · 42 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 2026-08-18 06:07:40 2026-07 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2017-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209112-001 ASCOR 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-10-02 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 N209112-001 AP 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209112-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209112-001 AP 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209112-001 AP 1 a50c72e98297…
Observed Orange Book exclusivity history# 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 Ascor ASCORBIC ACID McGuff Pharmaceuticals, Inc. 388aad52-fc01-4784-9791-1dbc80c69306 2026-05-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 209112 application number: NDA209112 ndc (product): 67157-101
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67157-101 Ascor Ascorbic Acid McGuff Pharmaceuticals, Inc. NDA Current 67157-101 Ascor Ascorbic Acid McGuff Pharmaceuticals, Inc. NDA Current 67157-101 Ascor Ascorbic Acid McGuff Pharmaceuticals, Inc. NDA Current 67157-101 Ascor Ascorbic Acid McGuff Pharmaceuticals, Inc. NDA Current 67157-101 Ascor Ascorbic Acid McGuff Pharmaceuticals, Inc. NDA Current 67157-101 Ascor Ascorbic Acid McGuff Pharmaceuticals, Inc. NDA Current 67157-101 Ascor Ascorbic Acid McGuff Pharmaceuticals, Inc. NDA Current 67157-101 Ascor Ascorbic Acid McGuff Pharmaceuticals, Inc. NDA Current 67157-101 Ascor Ascorbic Acid McGuff Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 80171 SUPPL 2024-11-05 80170 SUPPL 2024-11-05 80165 SUPPL 2024-11-05 77302 SUPPL 2024-01-25 77301 SUPPL 2024-01-25 71543 SUPPL 2022-07-13 71532 SUPPL 2022-07-11 52670 ORIG 2018-02-20 49937 ORIG 2017-10-04 49935 ORIG 2017-10-03