Application 206614

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RITONAVIR	RITONAVIR	TABLET;ORAL	100MG	No	No

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

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
A206614-001	RITONAVIR	RITONAVIR	100MG	TABLET / ORAL	AB	RS	2018-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206614-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB	RS	2018-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB	RS	2018-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206614-001	RITONAVIR	100MG	TABLET / ORAL	AB		2018-09-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206614-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206614-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206614-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206614-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206614-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206614-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206614-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206614-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206614-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206614-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206614-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206614-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206614-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206614-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206614-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206614-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206614-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206614-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206614-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206614-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206614-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206614-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206614-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206614-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206614-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206614-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206614-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206614-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206614-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206614-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206614-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206614-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206614-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206614-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206614-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206614-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206614-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206614-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206614-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206614-001	AB	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ritonavir	RITONAVIR	Bryant Ranch Prepack	d2f8c6ba-5e06-4b03-8ca5-b4fd7e5a8925	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206614 application number: ANDA206614
Ritonavir	RITONAVIR	NuCare Pharmaceuticals, Inc.	3f92f1e2-59f4-f6c4-e063-6294a90a487b	2025-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206614 application number: ANDA206614
Ritonavir	RITONAVIR	American Health Packaging	19503bc4-3443-4ad4-aa27-437f4f3288b1	2024-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206614 application number: ANDA206614 ndc (product): 60687-420
Ritonavir	RITONAVIR	Aurobindo Pharma Limited	11f757f1-cf48-47a8-925e-918359cbd2d4	2023-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206614 application number: ANDA206614 ndc (product): 65862-687

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60687-420	Ritonavir	Ritonavir	American Health Packaging	ANDA	Current
60687-420	Ritonavir	Ritonavir	American Health Packaging	ANDA	Current
60687-420	Ritonavir	Ritonavir	American Health Packaging	ANDA	Current
60687-420	Ritonavir	Ritonavir	American Health Packaging	ANDA	Current
65862-687	Ritonavir	Ritonavir	Aurobindo Pharma Limited	ANDA	Current
65862-687	Ritonavir	Ritonavir	Aurobindo Pharma Limited	ANDA	Current
65862-687	Ritonavir	Ritonavir	Aurobindo Pharma Limited	ANDA	Current
65862-687	Ritonavir	Ritonavir	Aurobindo Pharma Limited	ANDA	Current
65862-687	Ritonavir	Ritonavir	Aurobindo Pharma Limited	ANDA	Current
70518-2007	Ritonavir	Ritonavir	REMEDYREPACK INC.	ANDA	Current
70518-2007	Ritonavir	Ritonavir	REMEDYREPACK INC.	ANDA	Current