Application 020531

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METROCREAM	METRONIDAZOLE	CREAM;TOPICAL	0.75%	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
N020531-001	METROCREAM	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	RLD	1995-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020531-001	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	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD	1995-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD	1995-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD	1995-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020531-001	METROCREAM	0.75%	CREAM / TOPICAL	AB	RLD, RS	1995-09-20	`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	N020531-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020531-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020531-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020531-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020531-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020531-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020531-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020531-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020531-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020531-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020531-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020531-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020531-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020531-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020531-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020531-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020531-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020531-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020531-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020531-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020531-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020531-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020531-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020531-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020531-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020531-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020531-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020531-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020531-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020531-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020531-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020531-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020531-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020531-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020531-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020531-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020531-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020531-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020531-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020531-001	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
METRONIDAZOLE	METRONIDAZOLE	Prasco Laboratories	a6ce81f5-a5c6-44d7-b5f0-61d0530345bd	2024-11-07	Adverse reactions	Exact identifier application applno (NDA): 020531 application number: NDA020531 ndc (product): 66993-960
METRONIDAZOLE	METRONIDAZOLE	Mayne Pharma Inc.	567c7c0c-ffc1-47c1-b0fb-8715bf3d76b9	2024-10-31	Adverse reactions	Exact identifier application applno (NDA): 020531 application number: NDA020531

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-3836	MetroCream	metronidazole	Galderma Laboratories, L.P.	NDA	Current
66993-960	METRONIDAZOLE	METRONIDAZOLE	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
69007-836	METRONIDAZOLE	METRONIDAZOLE	Owen Laboratories	NDA AUTHORIZED GENERIC	Current
72189-306	Metronidazole Topical Cream	Metronidazole Topical Cream	DirectRx	NDA AUTHORIZED GENERIC	Current
72189-306	Metronidazole Topical Cream	Metronidazole Topical Cream	DirectRx	NDA AUTHORIZED GENERIC	Current