FDA.reportPublic FDA data

Application 020715

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRELSTARTRIPTORELIN PAMOATEINJECTABLE;INTRAMUSCULAREQ 3.75MG BASE/VIALYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020715-001TRELSTARTRIPTORELIN PAMOATEEQ 3.75MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2000-06-15

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020715-001TRELSTAREQ 3.75MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2000-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020715-001TRELSTAREQ 3.75MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2000-06-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020715-001TRELSTAREQ 3.75MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2000-06-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020715-001TRELSTAREQ 3.75MG BASE/VIALINJECTABLE / INTRAMUSCULARRLD, RS2000-06-15a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrelstarTRIPTORELIN PAMOATEVerity Pharmaceuticals Inc.b1b84d62-a369-a4b7-5c41-dd1f553a18f32026-06-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 020715
application number: NDA020715
ndc (product): 74676-5902

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5902Trelstartriptorelin pamoateAllergan, Inc.NDACurrent
0023-5902Trelstartriptorelin pamoateAllergan, Inc.NDACurrent
74676-5902Trelstartriptorelin pamoateVerity Pharmaceuticals Inc.NDACurrent
74676-5902Trelstartriptorelin pamoateVerity Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83477SUPPL 2025-09-25
83432SUPPL 2025-09-25
81570SUPPL 2025-03-14
81550SUPPL 2025-03-13
78142SUPPL 2024-04-15
78129SUPPL 2024-04-15
76639SUPPL 2023-11-21
76633SUPPL 2023-11-20
73689SUPPL 2023-03-06
73685SUPPL 2023-03-06
56908SUPPL2018-12-21
56782SUPPL2018-12-18
25621SUPPL2014-07-15
13279SUPPL2014-07-15
25620SUPPL2013-03-15
13278SUPPL2013-03-15
23595ORIG2011-12-20
25619SUPPL2011-05-24
35210SUPPL2011-05-23
35209SUPPL2011-01-20
3184SUPPL2011-01-20
3183SUPPL2008-04-16
25618SUPPL2005-10-25
20873ORIG2002-07-31
25617SUPPL2002-01-15
3182SUPPL2002-01-15
35208ORIG2000-06-15
25616ORIG2000-06-15