Application 021302

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELIDEL	PIMECROLIMUS	CREAM;TOPICAL	1%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021302-001	ELIDEL	PIMECROLIMUS	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021302-001	AB

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021302-001	ELIDEL	1%	CREAM / TOPICAL	AB	RLD, RS	2001-12-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021302-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021302-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021302-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021302-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021302-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021302-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021302-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021302-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021302-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021302-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021302-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021302-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021302-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021302-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021302-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021302-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021302-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021302-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021302-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021302-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021302-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021302-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021302-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021302-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021302-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021302-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021302-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021302-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021302-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021302-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021302-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021302-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021302-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021302-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021302-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021302-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021302-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021302-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021302-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021302-001	AB	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pimecrolimus	PIMECROLIMUS	Oceanside Pharmaceuticals	6601e43e-ce7d-446a-8568-8e7b24b86f06	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021302 application number: NDA021302 ndc (product): 68682-110 ndc (product): 68682-112 ndc (product): 68682-111
Pimecrolimus	PIMECROLIMUS	Bryant Ranch Prepack	dc8708ec-16be-4c27-8a5e-bf84723408fe	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021302 application number: NDA021302

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-5100	ELIDEL	Pimecrolimus	Bausch Health US, LLC	NDA	Current
0187-5100	ELIDEL	Pimecrolimus	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5100	ELIDEL	Pimecrolimus	Bausch Health US LLC	NDA	Current
0187-5101	ELIDEL	Pimecrolimus	Bausch Health US, LLC	NDA	Current
0187-5101	ELIDEL	Pimecrolimus	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5101	ELIDEL	Pimecrolimus	Bausch Health US LLC	NDA	Current
0187-5102	ELIDEL	Pimecrolimus	Bausch Health US, LLC	NDA	Current
0187-5102	ELIDEL	Pimecrolimus	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5102	ELIDEL	Pimecrolimus	Bausch Health US LLC	NDA	Current
0187-5103	ELIDEL	Pimecrolimus	Bausch Health US, LLC	NDA	Current
0187-5103	ELIDEL	Pimecrolimus	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5103	ELIDEL	Pimecrolimus	Bausch Health US LLC	NDA	Current
68682-110	Pimecrolimus	Pimecrolimus	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-110	Pimecrolimus	Pimecrolimus	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-110	Pimecrolimus	Pimecrolimus	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-111	Pimecrolimus	Pimecrolimus	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-111	Pimecrolimus	Pimecrolimus	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-111	Pimecrolimus	Pimecrolimus	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-112	Pimecrolimus	Pimecrolimus	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-112	Pimecrolimus	Pimecrolimus	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-112	Pimecrolimus	Pimecrolimus	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
4968	SUPPL	2014-04-02
15138	SUPPL	2014-04-01
43739	ORIG	2011-01-13
27419	SUPPL	2010-07-23
36614	SUPPL	2010-07-22
15137	SUPPL	2007-08-14
4967	SUPPL	2007-08-14
4966	SUPPL	2006-01-30
36613	SUPPL	2006-01-19
15136	SUPPL	2004-12-03
27418	SUPPL	2004-12-02
36612	SUPPL	2003-10-17
27417	SUPPL	2003-10-17
42090	ORIG	2001-12-13
36611	ORIG	2001-12-13
4965	ORIG	2001-12-13