Home Applications 078593 Application 078593
Type ANDA
Sponsor WOCKHARDT Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE INJECTABLE;SUBCUTANEOUS EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078593-001 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) SOLUTION / SUBCUTANEOUS AP 2009-02-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078593-001 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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 A078593-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2009-02-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078593-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2009-02-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078593-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2009-02-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078593-001 SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP 2009-02-06 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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.
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55648-728 Sumatriptan Succinate Sumatriptan Succinate Wockhardt Limited ANDA Current 64679-728 Sumatriptan Succinate Sumatriptan Succinate Wockhardt USA LLC. ANDA Current 64679-728 Sumatriptan Succinate Sumatriptan Succinate Wockhardt USA LLC. ANDA Current 64679-728 Sumatriptan Succinate Sumatriptan Succinate Wockhardt USA LLC. ANDA Current 71205-111 Sumatriptan Succinate Sumatriptan Succinate Proficient Rx LP ANDA Current 71205-111 Sumatriptan Succinate Sumatriptan Succinate Proficient Rx LP ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 39562 ORIG 2009-02-06