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 44 .
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.
Product history page 4 of 4 · 132 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 N021332-001 SYMLIN EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) INJECTABLE / SUBCUTANEOUS 2005-03-16 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021332-002 SYMLIN EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD 2007-09-25 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021332-003 SYMLIN EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2007-09-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021332-001 SYMLIN EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) INJECTABLE / SUBCUTANEOUS 2005-03-16 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021332-002 SYMLIN EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD 2007-09-25 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021332-003 SYMLIN EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2007-09-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021332-001 SYMLIN EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) INJECTABLE / SUBCUTANEOUS 2005-03-16 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021332-002 SYMLIN EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD 2007-09-25 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021332-003 SYMLIN EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD, RS 2007-09-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021332-001 SYMLIN EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) INJECTABLE / SUBCUTANEOUS 2005-03-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021332-002 SYMLIN EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD 2007-09-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021332-003 SYMLIN EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) INJECTABLE / SUBCUTANEOUS RLD 2007-09-25 a50c72e98297…
Observed Orange Book patent history# 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 N021332-001 5686411 2019-03-16 U-638 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021332-002 5686411 2019-03-16 U-638 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021332-003 5686411 2019-03-16 U-638 Drug substance, Drug product 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021332-001 5686411 2019-03-16 U-638 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021332-002 5686411 2019-03-16 U-638 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021332-003 5686411 2019-03-16 U-638 Drug substance, Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021332-001 5686411 2019-03-16 U-638 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021332-002 5686411 2019-03-16 U-638 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021332-003 5686411 2019-03-16 U-638 Drug substance, Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021332-001 5686411 2019-03-16 U-638 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021332-002 5686411 2019-03-16 U-638 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021332-003 5686411 2019-03-16 U-638 Drug substance, Drug product ea99ee380514…
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 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