Home Applications 021332 Application 021332
Type NDA
Sponsor ASTRAZENECA AB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SYMLIN PRAMLINTIDE ACETATE INJECTABLE;SUBCUTANEOUS EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) No No 002 SYMLIN PRAMLINTIDE ACETATE INJECTABLE;SUBCUTANEOUS EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) Yes No 003 SYMLIN PRAMLINTIDE ACETATE INJECTABLE;SUBCUTANEOUS EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021332-001 SYMLIN PRAMLINTIDE ACETATE EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) INJECTABLE / SUBCUTANEOUS 2005-03-16 N021332-002 SYMLIN PRAMLINTIDE ACETATE EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD 2007-09-25 N021332-003 SYMLIN PRAMLINTIDE ACETATE EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD 2007-09-25
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 2026-08-01 22:54:32 2026-06 N021332-001 SYMLIN EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) INJECTABLE / SUBCUTANEOUS 2005-03-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N021332-002 SYMLIN EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD 2007-09-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N021332-003 SYMLIN EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD 2007-09-25 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0310-6615 SymlinPen pramlintide acetate AstraZeneca Pharmaceuticals LP NDA Current 0310-6615 SymlinPen pramlintide acetate AstraZeneca Pharmaceuticals LP NDA Current 0310-6615 SymlinPen pramlintide acetate AstraZeneca Pharmaceuticals LP NDA Current 0310-6627 SymlinPen pramlintide acetate AstraZeneca Pharmaceuticals LP NDA Current 0310-6627 SymlinPen pramlintide acetate AstraZeneca Pharmaceuticals LP NDA Current 0310-6627 SymlinPen pramlintide acetate AstraZeneca Pharmaceuticals LP NDA Current