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 42.

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	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 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2007-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2007-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2007-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2007-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2007-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2007-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2007-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2007-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2007-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021332-002	SYMLIN	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2007-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021332-003	SYMLIN	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2007-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021332-001	SYMLIN	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE / SUBCUTANEOUS		2005-03-16	`1e350fbaab3a…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SymlinPen	PRAMLINTIDE ACETATE	AstraZeneca Pharmaceuticals LP	4aea30ff-eb0d-45c1-b114-3127966328ff	2019-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021332 application number: NDA021332 ndc (product): 0310-6627 ndc (product): 0310-6615

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61383	SUPPL	2019-12-23
61358	SUPPL	2019-12-19
47544	SUPPL	2017-03-14
27501	SUPPL	2015-08-11
27502	SUPPL	2015-04-13
36673	SUPPL	2015-03-24
15206	SUPPL	2015-03-03
5062	SUPPL	2015-02-27
36672	SUPPL	2014-07-01
15205	SUPPL	2014-07-01
27499	SUPPL	2014-06-30
5060	SUPPL	2014-06-30
27500	SUPPL	2012-01-05
5061	SUPPL	2008-08-06
27498	SUPPL	2007-10-04
36671	SUPPL	2007-09-26
23256	ORIG	2007-02-28
42103	ORIG	2005-06-14
36670	ORIG	2005-03-18
5059	ORIG	2005-03-18