Application 206163

Type: ANDA
Sponsor: PIRAMAL CRITICAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	100MCG/VIAL	No	No
002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	500MCG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206163-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS			2016-06-29
A206163-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS			2016-06-29

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2016-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS		2016-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206163-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206163-002	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2016-06-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A206163-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206163-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206163-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206163-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206163-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206163-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206163-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206163-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206163-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206163-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206163-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206163-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206163-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206163-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206163-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206163-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206163-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206163-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206163-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206163-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206163-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206163-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206163-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206163-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206163-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206163-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206163-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206163-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206163-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206163-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206163-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206163-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206163-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206163-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206163-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206163-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206163-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206163-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206163-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206163-002	AP	1	`782e0a99824c…`

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
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Piramal Critical Care, Inc.	76139990-1355-cfb6-e053-2991aa0ace5b	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206163 application number: ANDA206163 ndc (product): 66794-201 ndc (product): 66794-200

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
66794-200	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	ANDA	Current
66794-200	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	ANDA	Current
66794-200	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	ANDA	Current
66794-201	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	ANDA	Current
66794-201	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	ANDA	Current
66794-201	Levothyroxine Sodium	Levothyroxine Sodium	Piramal Critical Care, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40527	ORIG	2016-07-18
32784	ORIG	2016-07-01