Home Applications 200744 Application 200744
Type ANDA
Sponsor FOUGERA PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TACROLIMUS TACROLIMUS OINTMENT;TOPICAL 0.03% No No 002 TACROLIMUS TACROLIMUS OINTMENT;TOPICAL 0.1% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200744-001 TACROLIMUS TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 A200744-002 TACROLIMUS TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 Tacrolimus TACROLIMUS E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 1bf44a84-14fd-4f80-ad8a-99b1431d631f 2026-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200744 application number: ANDA200744 ndc (product): 0168-0416 ndc (product): 0168-0417
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-3428 Tacrolimus tacrolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0093-3429 Tacrolimus tacrolimus Teva Pharmaceuticals USA, Inc. ANDA Current 0168-0416 Tacrolimus tacrolimus E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0416 Tacrolimus tacrolimus E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0416 Tacrolimus tacrolimus E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0417 Tacrolimus tacrolimus E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0417 Tacrolimus tacrolimus E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0417 Tacrolimus tacrolimus E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 68308-703 Tacrolimus tacrolimus Mayne Pharma Inc. ANDA Current 68308-703 Tacrolimus tacrolimus Mayne Pharma Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 58716 ORIG 2019-05-15 9849 ORIG 2014-09-10