Home Applications 022010 Application 022010
Type NDA
Sponsor DEPROCO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SEPTOCAINE ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE INJECTABLE;INJECTION 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ 0.005MG BASE/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog .
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.
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 2019-12-13 00:20 UTC 2019-12 N022010-001 SEPTOCAINE 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ 0.005MG BASE/ML) INJECTABLE / INJECTION AP RLD, RS 2006-03-30 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022010-001 SEPTOCAINE 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ 0.005MG BASE/ML) INJECTABLE / INJECTION AP RLD, RS 2006-03-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022010-001 SEPTOCAINE 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ 0.005MG BASE/ML) INJECTABLE / INJECTION AP RLD, RS 2006-03-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022010-001 SEPTOCAINE 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ 0.005MG BASE/ML) INJECTABLE / INJECTION AP RLD, RS 2006-03-30 ea99ee380514…
Observed Orange Book normalized TE history# Documents# Document, Submission type, Date table Document Submission type Date 42385 ORIG 2008-09-05 6676 ORIG 2006-04-07