Home Applications 076744 Application 076744
Type ANDA
Sponsor PAR PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TESTOSTERONE TESTOSTERONE GEL;TRANSDERMAL 25MG/2.5GM PACKET No No 002 TESTOSTERONE TESTOSTERONE GEL;TRANSDERMAL 50MG/5GM PACKET 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 A076744-001 TESTOSTERONE TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 A076744-002 TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23
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 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL 2007-05-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076744-001 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076744-002 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2007-05-23 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 79 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 · 17 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49884-418 Testosterone Testosterone Par Pharmaceutical, Inc. ANDA Current 49884-418 Testosterone Testosterone Par Pharmaceutical, Inc. ANDA Current 49884-418 Testosterone Testosterone Par Pharmaceutical, Inc. ANDA Current 49884-418 Testosterone Testosterone Par Pharmaceutical, Inc. ANDA Current 49884-418 Testosterone Testosterone Par Pharmaceutical, Inc. ANDA Current 49884-510 Testosterone Testosterone Par Pharmaceutical, Inc. ANDA Current 49884-510 Testosterone Testosterone Par Pharmaceutical, Inc. ANDA Current 49884-510 Testosterone Testosterone Par Pharmaceutical, Inc. ANDA Current 49884-510 Testosterone Testosterone Par Pharmaceutical, Inc. ANDA Current 49884-510 Testosterone Testosterone Par Pharmaceutical, Inc. ANDA Current 63629-2124 Testosterone Testosterone Bryant Ranch Prepack ANDA Current 63629-2124 Testosterone Testosterone Bryant Ranch Prepack ANDA Current 63629-2124 Testosterone Testosterone Bryant Ranch Prepack ANDA Current 63629-2125 Testosterone Testosterone Bryant Ranch Prepack ANDA Current 63629-2125 Testosterone Testosterone Bryant Ranch Prepack ANDA Current 64380-151 Testosterone Testosterone Strides Pharma Science Limited ANDA Current 64380-152 Testosterone Testosterone Strides Pharma Science Limited ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 43102 ORIG 2012-06-28