Home Applications 021015 Application 021015
Type NDA
Sponsor ABBVIE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ANDROGEL TESTOSTERONE GEL;TRANSDERMAL 25MG/2.5GM PACKET Yes No 002 ANDROGEL TESTOSTERONE GEL;TRANSDERMAL 50MG/5GM PACKET Yes Yes 003 ANDROGEL TESTOSTERONE GEL, METERED;TRANSDERMAL 12.5MG/1.25GM ACTUATION Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021015-001 ANDROGEL TESTOSTERONE 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / TRANSDERMAL AB1 RLD 2000-02-28 N021015-002 ANDROGEL TESTOSTERONE 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / TRANSDERMAL AB1 RLD 2000-02-28 N021015-003 ANDROGEL TESTOSTERONE 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL, METERED / TRANSDERMAL AB1 RLD 2003-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2 of 4 · 129 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 2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021015-002 ANDROGEL 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / TRANSDERMAL RLD 2000-02-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL, METERED / TRANSDERMAL RLD 2003-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021015-001 ANDROGEL 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / TRANSDERMAL RLD 2000-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021015-002 ANDROGEL 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / TRANSDERMAL RLD 2000-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL, METERED / TRANSDERMAL RLD 2003-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021015-001 ANDROGEL 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / TRANSDERMAL RLD 2000-02-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021015-002 ANDROGEL 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / TRANSDERMAL RLD 2000-02-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL, METERED / TRANSDERMAL RLD 2003-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021015-001 ANDROGEL 25MG/2.5GM PACKET GEL / TRANSDERMAL RLD 2000-02-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021015-002 ANDROGEL 50MG/5GM PACKET GEL / TRANSDERMAL RLD 2000-02-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL, METERED / TRANSDERMAL RLD 2003-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021015-001 ANDROGEL 25MG/2.5GM PACKET GEL / TRANSDERMAL RLD 2000-02-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021015-002 ANDROGEL 50MG/5GM PACKET GEL / TRANSDERMAL RLD 2000-02-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL RLD 2003-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021015-001 ANDROGEL 25MG/2.5GM PACKET GEL / TRANSDERMAL RLD 2000-02-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021015-002 ANDROGEL 50MG/5GM PACKET GEL / TRANSDERMAL RLD 2000-02-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL RLD 2003-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021015-001 ANDROGEL 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 RLD 2000-02-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-002 ANDROGEL 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RLD, RS 2000-02-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB RLD, RS 2003-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021015-001 ANDROGEL 25MG/2.5GM PACKET GEL / TRANSDERMAL RLD 2000-02-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021015-002 ANDROGEL 50MG/5GM PACKET GEL / TRANSDERMAL RLD 2000-02-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL, METERED / TRANSDERMAL RLD 2003-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021015-001 ANDROGEL 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 RLD 2000-02-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021015-002 ANDROGEL 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RLD, RS 2000-02-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** GEL, METERED / TRANSDERMAL RLD 2003-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-001 ANDROGEL 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 RLD 2000-02-28 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-002 ANDROGEL 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RLD, RS 2000-02-28 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL RLD 2003-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021015-001 ANDROGEL 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 RLD 2000-02-28 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021015-002 ANDROGEL 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RLD, RS 2000-02-28 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL RLD 2003-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021015-001 ANDROGEL 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 RLD 2000-02-28 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021015-002 ANDROGEL 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RLD, RS 2000-02-28 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL RLD 2003-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021015-001 ANDROGEL 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 RLD 2000-02-28 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021015-002 ANDROGEL 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RLD, RS 2000-02-28 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021015-003 ANDROGEL 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL RLD 2003-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021015-001 ANDROGEL 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 RLD 2000-02-28 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021015-002 ANDROGEL 50MG/5GM PACKET GEL / TRANSDERMAL AB1 RLD, RS 2000-02-28 3f01610625f2…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 55 observed states.
Observed Orange Book patent history# Patent history page 1 of 4 · 135 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021015-001 6503894 2020-08-30 U-490 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-001 9125816 2020-08-30 U-490 2015-09-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-001 9132089 2020-08-30 U-490 2015-09-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-001 6503894*PED 2021-03-01 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-001 9125816*PED 2021-03-02 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-001 9132089*PED 2021-03-02 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-002 6503894 2020-08-30 U-490 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-002 9125816 2020-08-30 U-490 2015-09-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-002 9132089 2020-08-30 U-490 2015-09-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-002 6503894*PED 2021-03-01 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-002 9125816*PED 2021-03-02 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-002 9132089*PED 2021-03-02 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-003 6503894 2020-08-30 U-490 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-003 9125816 2020-08-30 U-490 2015-09-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-003 9132089 2020-08-30 U-490 2015-09-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-003 6503894*PED 2021-03-01 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-003 9125816*PED 2021-03-02 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021015-003 9132089*PED 2021-03-02 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021015-001 6503894*PED 2021-03-01 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021015-001 9125816*PED 2021-03-02 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021015-001 9132089*PED 2021-03-02 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021015-002 6503894*PED 2021-03-01 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021015-002 9125816*PED 2021-03-02 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021015-002 9132089*PED 2021-03-02 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021015-003 6503894*PED 2021-03-01 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021015-003 9125816*PED 2021-03-02 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021015-003 9132089*PED 2021-03-02 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-001 6503894*PED 2021-03-01 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-001 9125816*PED 2021-03-02 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-001 9132089*PED 2021-03-02 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-002 6503894*PED 2021-03-01 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-002 9125816*PED 2021-03-02 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-002 9132089*PED 2021-03-02 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-003 6503894*PED 2021-03-01 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-003 9125816*PED 2021-03-02 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021015-003 9132089*PED 2021-03-02 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021015-001 6503894*PED 2021-03-01 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021015-001 9125816*PED 2021-03-02 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021015-001 9132089*PED 2021-03-02 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021015-002 6503894*PED 2021-03-01 Pediatric extension 5aa47cf7b7d7…
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 Testosterone TESTOSTERONE Prasco Laboratories 68b2375d-0365-4797-bc3d-63531c9f42fd 2024-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021015 application number: NDA021015
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0051-8425 Androgel Testosterone AbbVie Inc. NDA Current 0051-8425 Androgel Testosterone AbbVie Inc. NDA Current 0051-8425 Androgel Testosterone AbbVie Inc. NDA Current 0051-8425 Androgel Testosterone AbbVie Inc. NDA Current 0051-8425 Androgel Testosterone AbbVie Inc. NDA Current 0051-8450 Androgel Testosterone AbbVie Inc. NDA Current 0051-8450 Androgel Testosterone AbbVie Inc. NDA Current 0051-8450 Androgel Testosterone AbbVie Inc. NDA Current 0051-8450 Androgel Testosterone AbbVie Inc. NDA Current 0051-8450 Androgel Testosterone AbbVie Inc. NDA Current 21695-112 Androgel testosterone Rebel Distributors Corp. NDA Current