Application 201952

Type: ANDA
Sponsor: MICRO LABS LTD INDIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	TABLET;ORAL	325MG;37.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET / ORAL			2012-12-14

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL	AB	2012-12-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201952-001	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	TABLET / ORAL		2012-12-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201952-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201952-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201952-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201952-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201952-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201952-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201952-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201952-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201952-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201952-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201952-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201952-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201952-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201952-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201952-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201952-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201952-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201952-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201952-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201952-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201952-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201952-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201952-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201952-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201952-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201952-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201952-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201952-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201952-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201952-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201952-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201952-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201952-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201952-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201952-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201952-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201952-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201952-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201952-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201952-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Asclemed USA, Inc.	82d8b70f-aebf-4b9a-89b1-183fc9e2ff59	2020-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201952 application number: ANDA201952 ndc (product): 76420-105

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-119	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Micro Labs Limited	ANDA	Current
42571-119	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Micro Labs Limited	ANDA	Current
42571-119	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Micro Labs Limited	ANDA	Current
42571-119	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Micro Labs Limited	ANDA	Current
42571-119	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Micro Labs Limited	ANDA	Current
68788-7712	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7712	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2784	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	REMEDYREPACK INC.	ANDA	Current
70518-2784	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	REMEDYREPACK INC.	ANDA	Current
76420-105	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Asclemed USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76114	ORIG	2023-11-02